Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077401
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT;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
06/20/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

MOMETASONE FUROATE

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT;TOPICAL Prescription No AB 077401 COSETTE
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT;TOPICAL Prescription No AB 077061 FOUGERA PHARMS
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT;TOPICAL Prescription No AB 078571 GLENMARK GENERICS
MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT;TOPICAL Prescription No AB 076067 PERRIGO NEW YORK

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