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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215398
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BEXAROTENE BEXAROTENE 1% GEL;TOPICAL Prescription AB 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
04/27/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215398Orig1s000ltr.pdf

BEXAROTENE

GEL;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BEXAROTENE BEXAROTENE 1% GEL;TOPICAL Prescription No AB 215398 AMNEAL
TARGRETIN BEXAROTENE 1% GEL;TOPICAL Prescription Yes AB 021056 BAUSCH
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