A listing is not an approval

The date shown is the marketing start date the labeler reported. Many new listings are generics, repackaged or relabeled products, or new package sizes. The marketing category (NDA, ANDA, BLA) on each product page says under what authority it is marketed.

Newest first

831 listings in the last 90 days

Recently listed finished products, newest first
ProductStrengthForm · routeLabelerListedProduct NDC
DeferiproneDeferiprone 500 mg/1TabletOralAvKAREAug 12, 202673190-095
Awiqliinsulin icodec-abaeInsulin icodec 700 U/mLInjection, SolutionSubcutaneousNovo Nordisk Pharmaceutical Industries, LPAug 11, 20260169-3170
Lidocainelidocaine hydrochlorideLidocaine hydrochloride 20 mg/mLJellyTopicalSentiss Pharmaceuticals LLCAug 11, 202670244-039
ChlorpromazineChlorpromazine hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.Aug 11, 202670518-4724
Paclitaxel 100mg per vialpaclitaxel protein-bound particlesPaclitaxel 100 mg/20mLInjection, Powder, Lyophilized, For suspensionIntravenousEXELAN PHARMACEUTICALS INC.Aug 11, 202676282-768
Desmopressin AcetateDesmopressin acetate 4 ug/mLInjection, SolutionIntravenous, SubcutaneousThe J. Molner Company LLCAug 11, 202683148-126
vancomycin hydrochlorideVancomycin hydrochloride 125 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Aug 10, 202623155-967
vancomycin hydrochlorideVancomycin hydrochloride 250 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Aug 10, 202623155-968
NitroglycerinNitroglycerin 4 mg/gOintmentRectalPadagis Israel Pharmaceuticals LtdAug 10, 202645802-932
BrivaracetamBrivaracetam 10 mg/mLSolutionOralAurobindo Pharma LimitedAug 10, 202659651-995
RanolazineRanolazine 500 mg/1Tablet, Extended releaseOralUmedica Laboratories USA Inc.Aug 10, 202660290-055
RanolazineRanolazine 1000 mg/1Tablet, Extended releaseOralUmedica Laboratories USA Inc.Aug 10, 202660290-056
Sacubitril and ValsartanSacubitril 24 mg/1; Valsartan 26 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.Aug 10, 202660290-085
Sacubitril and ValsartanSacubitril 49 mg/1; Valsartan 51 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.Aug 10, 202660290-086
Sacubitril and ValsartanSacubitril 97 mg/1; Valsartan 103 mg/1Tablet, Film coatedOralUmedica Laboratories USA Inc.Aug 10, 202660290-087
Acamprosate CalciumAcamprosate calcium 333 mg/1Tablet, Delayed releaseOralSomerset Therapeutics, LLCAug 10, 202670069-860
TicagrelorTicagrelor 60 mg/1Tablet, Film coatedOralNorthStar RxLLCAug 10, 202672603-940
TicagrelorTicagrelor 90 mg/1Tablet, Film coatedOralNorthStar RxLLCAug 10, 202672603-941
TemozolomideTemozolomide 5 mg/1CapsuleOralCivicaScript LLCAug 10, 202682249-404
TemozolomideTemozolomide 20 mg/1CapsuleOralCivicaScript LLCAug 10, 202682249-406
TemozolomideTemozolomide 100 mg/1CapsuleOralCivicaScript LLCAug 10, 202682249-408
TemozolomideTemozolomide 140 mg/1CapsuleOralCivicaScript LLCAug 10, 202682249-410
TemozolomideTemozolomide 180 mg/1CapsuleOralCivicaScript LLCAug 10, 202682249-412
TemozolomideTemozolomide 250 mg/1CapsuleOralCivicaScript LLCAug 10, 202682249-414
FluconazoleFluconazole 50 mg/1TabletOralREMEDYREPACK INC.Aug 8, 202670518-4723

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