Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213601
Company: XIROMED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOCONAZOLE KETOCONAZOLE 2% AEROSOL, FOAM;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
05/21/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

KETOCONAZOLE

AEROSOL, FOAM;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EXTINA KETOCONAZOLE 2% AEROSOL, FOAM;TOPICAL Prescription Yes AB 021738 MYLAN
KETOCONAZOLE KETOCONAZOLE 2% AEROSOL, FOAM;TOPICAL Prescription No AB 091550 PADAGIS ISRAEL
KETOCONAZOLE KETOCONAZOLE 2% AEROSOL, FOAM;TOPICAL Prescription No AB 213601 XIROMED

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