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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088138
Company: CMP PHARMA INC

Products on ANDA 088138

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088138

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/1985	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
01/07/1991	SUPPL-7	Labeling		Label is not available on this site.
09/05/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/05/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088138

HYDROCORTISONE IN ABSORBASE

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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