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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086257
Company: TARO

Products on ANDA 086257

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/1978	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
04/29/1993	SUPPL-25	Labeling		Label is not available on this site.
10/19/1992	SUPPL-24	Labeling		Label is not available on this site.
04/16/1991	SUPPL-23	Labeling		Label is not available on this site.
11/21/1990	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/21/1989	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
02/07/1989	SUPPL-20	Labeling		Label is not available on this site.
04/11/1988	SUPPL-18	Labeling		Label is not available on this site.
07/24/1986	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/08/1985	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/26/1983	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/03/1984	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/24/1982	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086257

HYDROCORTISONE

OINTMENT;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE	HYDROCORTISONE	1%	OINTMENT;TOPICAL	Prescription	Yes	AT	080692	FOUGERA PHARMS
HYDROCORTISONE	HYDROCORTISONE	1%	OINTMENT;TOPICAL	Prescription	No	AT	086257	TARO
HYDROCORTISONE IN ABSORBASE	HYDROCORTISONE	1%	OINTMENT;TOPICAL	Prescription	No	AT	088138	CMP PHARMA INC

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