Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081203
Company: FOUGERA PHARMS INC

Products on ANDA 081203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE	HYDROCORTISONE	2.5%	OINTMENT;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 081203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/1993	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
04/01/1997	SUPPL-7	Labeling		Label is not available on this site.
03/07/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/06/1996	SUPPL-5	Labeling		Label is not available on this site.
03/06/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/06/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/06/1996	SUPPL-2	Labeling		Label is not available on this site.
03/06/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 081203

HYDROCORTISONE

OINTMENT;TOPICAL; 2.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE	HYDROCORTISONE	2.5%	OINTMENT;TOPICAL	Prescription	No	AT	081203	FOUGERA PHARMS INC
HYDROCORTISONE	HYDROCORTISONE	2.5%	OINTMENT;TOPICAL	Prescription	No	AT	085027	PADAGIS US