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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074392
Company: FOUGERA PHARMS INC

Products on ANDA 074392

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074392

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/1996	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
08/14/2006	SUPPL-7	Labeling		Label is not available on this site.
03/03/2000	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/03/2000	SUPPL-3	Labeling		Label is not available on this site.
12/15/1997	SUPPL-2	Labeling		Label is not available on this site.
12/15/1997	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074392

CLOBETASOL PROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	213291	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211256	AMNEAL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	075338	AUROBINDO PHARMA USA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	074139	COSETTE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	212982	ENCUBE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	074392	FOUGERA PHARMS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	209095	GLENMARK PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	210208	LUPIN LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211401	RISING
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	074249	TARO
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	210034	XIROMED
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211074	ZYDUS PHARMS

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