Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077061
Company: FOUGERA PHARMS

Products on ANDA 077061

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 077061

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2005	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
10/31/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077061

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