Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088799
Company: TARO

Products on ANDA 088799

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/1984	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
04/28/2005	SUPPL-30	Labeling		Label is not available on this site.
07/28/2005	SUPPL-27	Labeling		Label is not available on this site.
04/29/1993	SUPPL-25	Labeling		Label is not available on this site.
11/16/1992	SUPPL-16	Labeling		Label is not available on this site.
02/21/1992	SUPPL-14	Labeling		Label is not available on this site.
12/17/1990	SUPPL-13	Labeling		Label is not available on this site.
07/13/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/13/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/05/1989	SUPPL-10	Labeling		Label is not available on this site.
03/28/1990	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/28/1990	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/24/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/06/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/03/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088799

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