Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087795
Company: ACTAVIS MID ATLANTIC

Products on ANDA 087795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE	HYDROCORTISONE	1%	CREAM;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/1983	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
04/26/2001	SUPPL-22	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
12/27/2000	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
12/21/1998	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/13/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/28/1996	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
02/07/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/18/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/15/1991	SUPPL-9	Labeling		Label is not available on this site.
07/26/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/12/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/13/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/12/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/12/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087795

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