Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075919
Company: FOUGERA PHARMS

Products on ANDA 075919

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075919

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2007	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
04/04/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/29/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075919

MOMETASONE FUROATE

LOTION;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%	LOTION;TOPICAL	Prescription	No	AB	075919	FOUGERA PHARMS
MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION;TOPICAL	Prescription	No	AB	090506	GLENMARK PHARMS LTD
MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION;TOPICAL	Prescription	No	AB	077180	PADAGIS ISRAEL
MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION;TOPICAL	Prescription	No	AB	076788	TARO