Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076973
Company: FOUGERA PHARMS

Products on ANDA 076973

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALCLOMETASONE DIPROPIONATE	ALCLOMETASONE DIPROPIONATE	0.05%	CREAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076973

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076973ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/31/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076973

ALCLOMETASONE DIPROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALCLOMETASONE DIPROPIONATE	ALCLOMETASONE DIPROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	076973	FOUGERA PHARMS
ALCLOMETASONE DIPROPIONATE	ALCLOMETASONE DIPROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	079061	GLENMARK PHARMS LTD
ALCLOMETASONE DIPROPIONATE	ALCLOMETASONE DIPROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB	076587	TARO