Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076067
Company: PERRIGO NEW YORK
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
03/18/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76067_Mometasone Furoate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76067.ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076067_mometasone-furoate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/29/2007 SUPPL-5 Labeling

Label is not available on this site.

04/05/2004 SUPPL-2 Labeling

Label is not available on this site.

01/06/2003 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/18/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76067_Mometasone Furoate_Approv.pdf

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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