Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080693
Company: FOUGERA PHARMS INC

Products on ANDA 080693

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080693

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1976	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
03/07/1996	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
06/10/1996	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
07/30/1987	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
02/10/1986	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
02/10/1986	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
02/10/1986	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
01/26/1984	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
05/11/1982	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080693

HYDROCORTISONE

CREAM;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALA-CORT	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	No	AT	080706	CROWN LABS
HYDROCORTISONE	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	No	AT	087795	ACTAVIS MID ATLANTIC
HYDROCORTISONE	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	Yes	AT	080693	FOUGERA PHARMS INC