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.

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831 listings in the last 90 days

Recently listed finished products, newest first
ProductStrengthForm · routeLabelerListedProduct NDC
Ammonium lactateAmmonium lactate 120 mg/gCreamTopicalZydus Lifesciences LimitedOct 2, 202670771-1988
Guanfacine ERguanfacineGuanfacine hydrochloride 1 mg/1Tablet, Extended releaseOralDirect_RxOct 2, 202672189-693
Ammonium lactateAmmonium lactate 120 mg/gCreamTopicalViona Pharmaceuticals IncOct 2, 202672578-203
SdamloamlodipineAmlodipine besylate 2.5 mg/2.5mgSolutionOralPangea Pharmaceuticals, LLCOct 2, 202681279-133
SdamloamlodipineAmlodipine besylate 10 mg/10mgSolutionOralPangea Pharmaceuticals, LLCOct 2, 202681279-135
Valacyclovir HydrochlorideValacyclovir hydrochloride 1 g/1Tablet, Film coatedOralNorthwind Health Company, LLCOct 2, 202682868-117
PerampanelPerampanel 2 mg/1Tablet, Film coatedOralAurobindo Pharma LimitedOct 2, 202684386-084
PerampanelPerampanel 4 mg/1Tablet, Film coatedOralAurobindo Pharma LimitedOct 2, 202684386-085
PerampanelPerampanel 6 mg/1Tablet, Film coatedOralAurobindo Pharma LimitedOct 2, 202684386-086
PerampanelPerampanel 8 mg/1Tablet, Film coatedOralAurobindo Pharma LimitedOct 2, 202684386-087
PerampanelPerampanel 10 mg/1Tablet, Film coatedOralAurobindo Pharma LimitedOct 2, 202684386-088
PerampanelPerampanel 12 mg/1Tablet, Film coatedOralAurobindo Pharma LimitedOct 2, 202684386-089
Utebzitebipenem pivoxilTebipenem pivoxil hydrobromide 300 mg/1Tablet, Film coatedOralGlaxoSmithKline LLCOct 1, 20260173-0956
Lactated Ringerssodium chloride, sodium lactate, potassium chloride, and calcium chlorideSodium chloride .6 g/100mL + 3 more ingredientsInjection, SolutionIntravenousB. Braun Medical Inc.Oct 1, 20260264-7500
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 25 mg/1Capsule, Extended releaseOralSandoz IncOct 1, 20260781-2731
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 30 mg/1Capsule, Extended releaseOralSandoz IncOct 1, 20260781-2732
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 35 mg/1Capsule, Extended releaseOralSandoz IncOct 1, 20260781-2733
Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride 40 mg/1Capsule, Extended releaseOralSandoz IncOct 1, 20260781-2734
ClaforancefotaximeCefotaxime sodium 1 g/1Injection, Powder, For solutionIntramuscular, IntravenousSteriMax Inc.Oct 1, 202621586-031
Gentamicin SulfateGentamicin sulfate 1 mg/gOintmentTopicalEncube Ethicals, Inc.Oct 1, 202621922-110
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-322
Diltiazem HydrochlorideDiltiazem hydrochloride 90 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-323
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-324
TopiramateTopiramate 25 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-325
TopiramateTopiramate 50 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLCOct 1, 202627808-326

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