| 2013-05-20 | ARGATROBAN IN SODIUM CHLORIDE NDA (022434) | EAGLE PHARMS | Manufacturing Change or Addition |
| 2013-05-20 | ANDROGEL NDA (021015) | ABBVIE | Labeling Revision |
| 2013-05-20 | ANDROGEL NDA (022309) | ABBVIE | Labeling Revision |
| 2013-05-17 | ULTRAVATE NDA (019968) | RANBAXY | Manufacturing Change or Addition |
| 2013-05-17 | TASIGNA NDA (022068) | NOVARTIS | Labeling Revision |
| 2013-05-17 | ANGIOMAX NDA (020873) | MEDICINES CO | Labeling Revision |
| 2013-05-16 | VIVELLE-DOT NDA (020538) | NOVARTIS | Labeling Revision |
| 2013-05-16 | PEGASYS BLA (103964) | HOFFMAN-LA ROCHE | Labeling Revision |
| 2013-05-16 | LANTUS NDA (021081) | SANOFI AVENTIS US | Labeling Revision |
| 2013-05-16 | LANOXIN PEDIATRIC NDA (009330) | COVIS PHARMA | Labeling Revision |
| 2013-05-16 | LANOXIN NDA (009330) | COVIS PHARMA | Labeling Revision |
| 2013-05-16 | INSPRA NDA (021437) | GD SEARLE LLC | Labeling Revision |
| 2013-05-16 | HABITROL NDA (020076) | NOVARTIS | Manufacturing Change or Addition |
| 2013-05-16 | ESTRADIOL NDA (020538) | NOVARTIS | Labeling Revision |
| 2013-05-15 | TRANSDERM SCOP NDA (017874) | NOVARTIS | Manufacturing Change or Addition |
| 2013-05-15 | SYLATRON BLA (103949) | SCHERING | Labeling Revision |
| 2013-05-15 | SIMPONI BLA (125289) | CENTOCOR ORTHO BIOTECH INC | Efficacy Supplement with Clinical Data to Support |
| 2013-05-15 | ROCALTROL NDA (021068) | VALIDUS PHARMS | Manufacturing Change or Addition |
| 2013-05-15 | QUILLIVANT XR NDA (202100) | NEXTWAVE PHARMS | Manufacturing Change or Addition |
| 2013-05-15 | PULMICORT RESPULES NDA (020929) | ASTRAZENECA | Manufacturing Change or Addition |
| 2013-05-15 | PRILOSEC NDA (019810) | ASTRAZENECA | Labeling Revision |
| 2013-05-15 | PEGINTRON BLA (103949) | SCHERING | Labeling Revision |
| 2013-05-15 | NORDITROPIN NORDIFLEX NDA (021148) | NOVO NORDISK INC | Manufacturing Change or Addition |
| 2013-05-15 | NORDITROPIN FLEXPRO NDA (021148) | NOVO NORDISK INC | Manufacturing Change or Addition |
| 2013-05-15 | NORDITROPIN NDA (021148) | NOVO NORDISK INC | Manufacturing Change or Addition |
| 2013-05-15 | KOMBIGLYZE XR NDA (200678) | BRISTOL MYERS SQUIBB | Manufacturing Change or Addition |
| 2013-05-15 | INFERGEN BLA (103663) | INTERMUNE PHARMS | Labeling Revision |
| 2013-05-15 | DUREZOL NDA (022212) | ALCON PHARMS LTD | Labeling Revision |
| 2013-05-15 | COLCRYS NDA (022352) | TAKEDA PHARMS USA | Manufacturing Change or Addition |
| 2013-05-15 | ALTOPREV NDA (021316) | ANDRX LABS LLC | Manufacturing Change or Addition |
| 2013-05-15 | ACCOLATE NDA (020547) | ASTRAZENECA | Manufacturing Change or Addition |
| 2013-05-14 | TARCEVA NDA (021743) | OSI PHARMS | New or Modified Indication |
| 2013-05-14 | RIDAURA NDA (018689) | PROMETHEUS LABS | Manufacturing Change or Addition |
| 2013-05-14 | RETIN-A NDA (017579) | VALEANT INTL | Manufacturing Change or Addition |
| 2013-05-14 | MEGACE ES NDA (021778) | PAR PHARM | Labeling Revision |
| 2013-05-14 | LUPRON DEPOT-PED NDA (020263) | ABBOTT ENDOCRINE | Labeling Revision |
| 2013-05-14 | CLIMARA NDA (020375) | BAYER HLTHCARE | Manufacturing Change or Addition |
| 2013-05-13 | ULTRA-TECHNEKOW FM NDA (017243) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-13 | PRILOSEC NDA (022056) | ASTRAZENECA | Labeling Revision |
| 2013-05-13 | PREPOPIK NDA (202535) | FERRING PHARMS AS | Manufacturing Change or Addition |
| 2013-05-13 | OPANA ER NDA (201655) | ENDO PHARMS | Approval |
| 2013-05-13 | HUMIRA BLA (125057) | ABBOTT | Labeling Revision |
| 2013-05-11 | TASMAR NDA (020697) | VALEANT PHARMS LLC | Labeling Revision |
| 2013-05-10 | ULTRA-TECHNEKOW FM NDA (017243) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | MEFOXIN NDA (050517) | MYLAN INSTITUTIONAL | Labeling Revision |
| 2013-05-10 | MD-76R NDA (019292) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | HUMULIN R PEN NDA (018780) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMULIN R NDA (018780) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMULIN N NDA (018781) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMULIN 70/30 PEN NDA (019717) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMULIN 70/30 NDA (019717) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMALOG PEN NDA (020563) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMALOG MIX 75/25 PEN NDA (021017) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMALOG MIX 75/25 KWIKPEN NDA (021017) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMALOG MIX 75/25 NDA (021017) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMALOG KWIKPEN NDA (020563) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | HUMALOG NDA (020563) | LILLY | Manufacturing Change or Addition |
| 2013-05-10 | CYSTO-CONRAY II NDA (017057) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | CYSTO-CONRAY NDA (017057) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | CYKLOKAPRON NDA (019281) | PHARMACIA AND UPJOHN | Labeling Revision |
| 2013-05-10 | CONRAY 43 NDA (013295) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | CONRAY 30 NDA (016983) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | CONRAY NDA (013295) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-10 | COMPLERA NDA (202123) | GILEAD SCIENCES INC | Manufacturing Change or Addition |
| 2013-05-10 | BESIVANCE NDA (022308) | BAUSCH AND LOMB | Manufacturing Change or Addition |
| 2013-05-09 | VEREGEN NDA (021902) | MEDIGENE AG | Manufacturing Change or Addition |
| 2013-05-09 | SYNALGOS-DC NDA (011483) | CARACO | Labeling Revision |
| 2013-05-09 | SOMA COMPOUND W/ CODEINE NDA (012366) | MEDA PHARMS | Labeling Revision |
| 2013-05-09 | RITUXAN BLA (103705) | GENENTECH | Labeling Revision |
| 2013-05-09 | PHENERGAN W/ CODEINE NDA (008306) | ANI PHARMS | Labeling Revision |
| 2013-05-09 | PHENERGAN VC W/ CODEINE NDA (008306) | ANI PHARMS | Labeling Revision |
| 2013-05-09 | INDOCIN NDA (018332) | IROKO PHARMS | Manufacturing Change or Addition |
| 2013-05-09 | ILARIS BLA (125319) | NOVARTIS PHARMS | Efficacy Supplement with Clinical Data to Support |
| 2013-05-09 | FIORINAL W/CODEINE NDA (019429) | WATSON LABS INC | Labeling Revision |
| 2013-05-09 | FIORICET W/ CODEINE NDA (020232) | WATSON LABS INC | Labeling Revision |
| 2013-05-09 | DAYTRANA NDA (021514) | NOVEN PHARMS INC | Manufacturing Change or Addition |
| 2013-05-09 | CODEINE SULFATE NDA (202245) | ROXANE | Labeling Revision |
| 2013-05-09 | CODEINE SULFATE NDA (022402) | ROXANE | Labeling Revision |
| 2013-05-08 | STERILE WATER IN PLASTIC CONTAINER NDA (016734) | B BRAUN | Manufacturing Change or Addition |
| 2013-05-08 | SORBITOL 3.3% IN PLASTIC CONTAINER NDA (016741) | B BRAUN | Manufacturing Change or Addition |
| 2013-05-08 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA (016733) | B BRAUN | Manufacturing Change or Addition |
| 2013-05-08 | QVAR 80 NDA (020911) | TEVA BRANDED PHARM | Manufacturing Change or Addition |
| 2013-05-08 | QVAR 40 NDA (020911) | TEVA BRANDED PHARM | Manufacturing Change or Addition |
| 2013-05-08 | PHYSIOLYTE IN PLASTIC CONTAINER NDA (019024) | B BRAUN | Manufacturing Change or Addition |
| 2013-05-08 | LOPROX NDA (021159) | MEDICIS | Labeling Revision |
| 2013-05-08 | LO LOESTRIN FE NDA (022501) | WARNER CHILCOTT LLC | Manufacturing Change or Addition |
| 2013-05-08 | INCIVEK NDA (201917) | VERTEX PHARMS | Manufacturing Change or Addition |
| 2013-05-08 | GRIS-PEG NDA (050475) | PEDINOL | Manufacturing Change or Addition |
| 2013-05-08 | GLYCINE 1.5% IN PLASTIC CONTAINER NDA (016784) | B BRAUN | Manufacturing Change or Addition |
| 2013-05-08 | FLECTOR NDA (021234) | INST BIOCHEM | Manufacturing Change or Addition |
| 2013-05-08 | ERIVEDGE NDA (203388) | GENENTECH | Manufacturing Change or Addition |
| 2013-05-07 | THYROGEN NDA (020898) | GENZYME | Manufacturing Change or Addition |
| 2013-05-07 | LYOPHILIZED CYTOXAN NDA (012142) | BAXTER HLTHCARE | Labeling Revision |
| 2013-05-07 | GEMZAR NDA (020509) | LILLY | Labeling Revision |
| 2013-05-07 | GEMCITABINE HYDROCHLORIDE ANDA (202485) | JIANGSU HANSOH PHARM | Approval |
| 2013-05-07 | GEMCITABINE ANDA (091597) | SAGENT PHARMS | Approval |
| 2013-05-07 | DYNA-HEX NDA (020111) | XTTRIUM | Labeling Revision |
| 2013-05-07 | CYTOXAN NDA (012141) | BAXTER HLTHCARE | Labeling Revision |
| 2013-05-07 | CYTOXAN NDA (012142) | BAXTER HLTHCARE | Labeling Revision |
| 2013-05-06 | VIDAZA NDA (050794) | CELGENE | Manufacturing Change or Addition |
| 2013-05-06 | TRIBENZOR NDA (200175) | DAIICHI SANKYO | Manufacturing Change or Addition |
| 2013-05-06 | SIMPONI BLA (125289) | CENTOCOR ORTHO BIOTECH INC | Labeling Revision |
| 2013-05-06 | RITALIN LA NDA (021284) | NOVARTIS | Labeling Revision |
| 2013-05-06 | OPTIMARK NDA (020937) | MALLINCKRODT | Manufacturing Change or Addition |
| 2013-05-06 | METADATE CD NDA (021259) | UCB INC | Labeling Revision |
| 2013-05-06 | HALDOL NDA (015923) | JANSSEN PHARMS | Labeling Revision |
| 2013-05-06 | HALDOL NDA (018701) | JANSSEN PHARMS | Labeling Revision |
| 2013-05-06 | DACOGEN NDA (021790) | EISAI INC | Manufacturing Change or Addition |
| 2013-05-06 | AVINZA NDA (021260) | KING PHARMS | Labeling Revision |
| 2013-05-03 | ZYVOX NDA (021130) | PHARMACIA AND UPJOHN | Labeling Revision |
| 2013-05-03 | ZYVOX NDA (021131) | PHARMACIA AND UPJOHN | Labeling Revision |
| 2013-05-03 | ZYVOX NDA (021132) | PHARMACIA AND UPJOHN | Labeling Revision |
| 2013-05-03 | XELJANZ NDA (203214) | PFIZER INC | Manufacturing Change or Addition |
| 2013-05-03 | TUDORZA PRESSAIR NDA (202450) | FOREST LABS INC | Manufacturing Change or Addition |
| 2013-05-03 | STRIBILD NDA (203100) | GILEAD SCIENCES INC | Manufacturing Change or Addition |
| 2013-05-03 | SANDIMMUNE NDA (050573) | NOVARTIS | Labeling Revision |
| 2013-05-03 | SANDIMMUNE NDA (050574) | NOVARTIS | Labeling Revision |
| 2013-05-03 | SANDIMMUNE NDA (050625) | NOVARTIS | Labeling Revision |
| 2013-05-03 | PROTOPAM CHLORIDE NDA (014134) | BAXTER HLTHCARE CORP | Manufacturing Change or Addition |
| 2013-05-03 | LOCOID NDA (018652) | PRECISION DERMAT | Manufacturing Change or Addition |
| 2013-05-03 | LOCOID NDA (019116) | PRECISION DERMAT | Manufacturing Change or Addition |
| 2013-05-03 | CONCERTA NDA (021121) | JANSSEN PHARMS | Labeling Revision |
| 2013-05-03 | CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA (050596) | SANOFI AVENTIS US | Manufacturing Change or Addition |
| 2013-05-03 | CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER NDA (050596) | SANOFI AVENTIS US | Manufacturing Change or Addition |
| 2013-05-03 | CANDESARTAN CILEXETIL ANDA (078702) | LEK PHARMS | Approval |
| 2013-05-03 | CANASA NDA (021252) | APTALIS PHARMA US | Manufacturing Change or Addition |
| 2013-05-02 | SUSTIVA NDA (020972) | BRISTOL MYERS SQUIBB | Efficacy Supplement with Clinical Data to Support |
| 2013-05-02 | SUSTIVA NDA (021360) | BRISTOL MYERS SQUIBB | Efficacy Supplement with Clinical Data to Support |
| 2013-05-02 | SAMSCA NDA (022275) | OTSUKA AMERICA PHARM | Labeling Revision |
| 2013-05-02 | NEORAL NDA (050716) | NOVARTIS | Labeling Revision |
| 2013-05-02 | NEORAL NDA (050715) | NOVARTIS | Labeling Revision |
| 2013-05-02 | CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER NDA (019734) | EKR THERAP | Manufacturing Change or Addition |
| 2013-05-02 | CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER NDA (019734) | EKR THERAP | Manufacturing Change or Addition |
| 2013-05-02 | CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER NDA (019734) | EKR THERAP | Manufacturing Change or Addition |
| 2013-05-02 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER NDA (019734) | EKR THERAP | Manufacturing Change or Addition |
| 2013-05-02 | CARDENE NDA (019734) | EKR THERAP | Manufacturing Change or Addition |
| 2013-05-01 | NEURONTIN NDA (020882) | PFIZER PHARMS | Labeling Revision |
| 2013-05-01 | NEURONTIN NDA (020235) | PFIZER PHARMS | Labeling Revision |
| 2013-05-01 | NEURONTIN NDA (021129) | PARKE DAVIS | Labeling Revision |
| 2013-05-01 | MYFORTIC NDA (050791) | NOVARTIS | Labeling Revision |
| 2013-05-01 | MYFORTIC NDA (050791) | NOVARTIS | Manufacturing Change or Addition |
| 2013-05-01 | LOESTRIN 24 FE NDA (021871) | WARNER CHILCOTT | Manufacturing Change or Addition |
| 2013-05-01 | HORIZANT NDA (022399) | GLAXO GRP LTD | Labeling Revision |
| 2013-05-01 | ARIMIDEX NDA (020541) | ASTRAZENECA | Labeling Revision |
| 2013-04-30 | TYVASO NDA (022387) | UNITED THERAP | Labeling Revision |
| 2013-04-30 | TRANSDERM SCOP NDA (017874) | NOVARTIS | Labeling Revision |
| 2013-04-30 | TASMAR NDA (020697) | VALEANT PHARMS LLC | Manufacturing Change or Addition |
| 2013-04-30 | SEROQUEL XR NDA (022047) | ASTRAZENECA | Labeling Revision |
| 2013-04-30 | SEROQUEL XR NDA (022047) | ASTRAZENECA | Efficacy Supplement with Clinical Data to Support |
| 2013-04-30 | SEROQUEL NDA (020639) | ASTRAZENECA | Labeling Revision |
| 2013-04-30 | SEROQUEL NDA (020639) | ASTRAZENECA | Efficacy Supplement with Clinical Data to Support |
| 2013-04-30 | PLAN B ONE-STEP NDA (021998) | DURAMED | Efficacy Supplement with Clinical Data to Support |
| 2013-04-30 | INTELENCE NDA (022187) | JANSSEN R AND D | Manufacturing Change or Addition |
| 2013-04-30 | AVODART NDA (021319) | GLAXOSMITHKLINE | Labeling Revision |
| 2013-04-29 | ZINACEF IN PLASTIC CONTAINER NDA (050643) | COVIS PHARMA | Manufacturing Change or Addition |
| 2013-04-29 | ZEMURON NDA (020214) | SCHERING | Manufacturing Change or Addition |
| 2013-04-29 | VIBRAMYCIN NDA (050006) | PFIZER | Labeling Revision |
| 2013-04-29 | VIBRAMYCIN NDA (050007) | PFIZER | Labeling Revision |
| 2013-04-29 | VIBRAMYCIN NDA (050480) | PFIZER | Labeling Revision |
| 2013-04-29 | VIBRA-TABS NDA (050533) | PFIZER | Labeling Revision |
| 2013-04-29 | SULFAMETHOXAZOLE AND TRIMETHOPRIM ANDA (073303) | TEVA PARENTERAL | Labeling Revision |
| 2013-04-29 | STELARA BLA (125261) | CENTOCOR ORTHO BIOTECH INC | Labeling Revision |
| 2013-04-29 | RHINOCORT NDA (020746) | ASTRAZENECA | Manufacturing Change or Addition |
| 2013-04-29 | NEXTERONE NDA (022325) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-29 | FORTAZ IN PLASTIC CONTAINER NDA (050634) | COVIS PHARMA | Manufacturing Change or Addition |
| 2013-04-29 | COARTEM NDA (022268) | NOVARTIS | Labeling Revision |
| 2013-04-29 | ACTEMRA BLA (125276) | GENENTECH | Efficacy Supplement with Clinical Data to Support |
| 2013-04-28 | CHILDREN'S ALLEGRA HIVES NDA (021909) | SANOFI AVENTIS US | Labeling Revision |
| 2013-04-28 | CHILDREN'S ALLEGRA HIVES NDA (201373) | SANOFI AVENTIS US | Labeling Revision |
| 2013-04-28 | CHILDREN'S ALLEGRA ALLERGY NDA (021909) | SANOFI AVENTIS US | Labeling Revision |
| 2013-04-28 | CHILDREN'S ALLEGRA ALLERGY NDA (201373) | SANOFI AVENTIS US | Labeling Revision |
| 2013-04-26 | VYVANSE NDA (021977) | SHIRE DEVELOPMENT | Efficacy Supplement with Clinical Data to Support |
| 2013-04-26 | TOTECT NDA (022025) | APRICUS PHARMS | Labeling Revision |
| 2013-04-26 | SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER NDA (016692) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | SALAGEN NDA (020237) | EISAI INC | Manufacturing Change or Addition |
| 2013-04-26 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA (019367) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA (019367) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA (019367) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA (019367) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA (019367) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER NDA (019367) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | LACTATED RINGER'S IN PLASTIC CONTAINER NDA (018494) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | LACTATED RINGER'S IN PLASTIC CONTAINER NDA (016682) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER NDA (016679) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | GLUCAGEN NDA (020918) | NOVO NORDISK | Labeling Revision |
| 2013-04-26 | GLUCAGEN NDA (020918) | NOVO NORDISK | Manufacturing Change or Addition |
| 2013-04-26 | EXTRANEAL NDA (021321) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | EDURANT NDA (202022) | JANSSEN PRODS | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER NDA (020163) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER NDA (020163) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER NDA (020163) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER NDA (020183) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER NDA (020183) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER NDA (020183) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER NDA (020183) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER NDA (017512) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER NDA (017484) | BAXTER HLTHCARE | Manufacturing Change or Addition |
| 2013-04-26 | CLARITIN-D 24 HOUR NDA (020470) | SCHERING PLOUGH | Manufacturing Change or Addition |
| 2013-04-26 | ATACAND HCT NDA (021093) | ASTRAZENECA | Labeling Revision |
| 2013-04-26 | ATACAND NDA (020838) | ASTRAZENECA | Labeling Revision |
| 2013-04-25 | TRELSTAR NDA (021288) | WATSON LABS | Manufacturing Change or Addition |
| 2013-04-25 | TRELSTAR NDA (022437) | WATSON LABS | Manufacturing Change or Addition |
| 2013-04-25 | TRELSTAR NDA (020715) | WATSON LABS | Manufacturing Change or Addition |
| 2013-04-25 | TACLONEX NDA (021852) | LEO PHARM | Manufacturing Change or Addition |
| 2013-04-25 | PRADAXA NDA (022512) | BOEHRINGER INGELHEIM | Labeling Revision |
| 2013-04-25 | JEVTANA KIT NDA (201023) | SANOFI AVENTIS US | Labeling Revision |
| 2013-04-25 | JALYN NDA (022460) | GLAXOSMITHKLINE | Labeling Revision |
| 2013-04-25 | INCIVEK NDA (201917) | VERTEX PHARMS | Labeling Revision |
| 2013-04-25 | HEPATOLITE NDA (018467) | PHARMALUCENCE | Manufacturing Change or Addition |