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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076067
Company: PADAGIS US

Products on ANDA 076067

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076067

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.

Labels for ANDA 076067

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

Therapeutic Equivalents for ANDA 076067

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 PHARMS INC
MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	OINTMENT;TOPICAL	Prescription	No	AB	076067	PADAGIS US

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