Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085025
Company: PADAGIS US

Products on ANDA 085025

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 085025

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/1983	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
12/27/1999	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
05/08/1996	SUPPL-17	Labeling		Label is not available on this site.
05/08/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/11/1986	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/02/1982	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/30/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 085025

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