Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089414
Company: FOUGERA PHARMS INC

Products on ANDA 089414

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089414

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1986	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-6	Labeling		Label is not available on this site.
03/07/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/08/1995	SUPPL-4	Labeling		Label is not available on this site.
11/08/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 089414

HYDROCORTISONE

CREAM;TOPICAL; 2.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALA-CORT	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	080706	CROWN LABS
ANUSOL HC	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	088250	SALIX PHARMS
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	089682	ACTAVIS MID ATLANTIC
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	089414	FOUGERA PHARMS INC
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	085025	PADAGIS US
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	040879	RISING
HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM;TOPICAL	Prescription	No	AT	088799	TARO