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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203663
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL 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
06/16/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

BEXAROTENE

CAPSULE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 210105 AMNEAL PHARMS NY
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 209861 ANI PHARMS
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 203174 BIONPHARMA INC
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 203663 HIKMA
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 209931 TEVA PHARMS USA
BEXAROTENE BEXAROTENE 75MG CAPSULE;ORAL Prescription No AB 209886 UPSHER SMITH LABS
TARGRETIN BEXAROTENE 75MG CAPSULE;ORAL Prescription Yes AB 021055 VALEANT LUXEMBOURG
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