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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080692
Company: FOUGERA PHARMS

Products on ANDA 080692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE	HYDROCORTISONE	1%	OINTMENT;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/1975	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
03/07/1996	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
11/08/1995	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/07/1995	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
07/30/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
01/26/1984	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/13/1982	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/13/1982	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/13/1982	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/13/1982	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/13/1982	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/13/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080692

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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