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Abbreviated New Drug Application (ANDA): 091314
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter None No No
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/01/2010 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/091314Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2019 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ADAPALENE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GEL;TOPICAL; 0.1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 091314 GLENMARK GENERICS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 091314 GLENMARK GENERICS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 090962 P AND L
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 215940 TARO PHARMS
DIFFERIN ADAPALENE 0.1% GEL;TOPICAL Over-the-counter Yes 020380 GALDERMA LABS LP

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GEL;TOPICAL; 0.1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 091314 GLENMARK GENERICS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 091314 GLENMARK GENERICS
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 090962 P AND L
ADAPALENE ADAPALENE 0.1% GEL;TOPICAL Over-the-counter No 215940 TARO PHARMS
DIFFERIN ADAPALENE 0.1% GEL;TOPICAL Over-the-counter Yes 020380 GALDERMA LABS LP
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