Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089074
Company: PADAGIS US

Products on ANDA 089074

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STIE-CORT	HYDROCORTISONE	2.5%	LOTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/1985	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
11/28/2007	SUPPL-15	Labeling		Label is not available on this site.
08/16/2001	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/03/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/14/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/14/1995	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/17/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/17/1996	SUPPL-9	Labeling		Label is not available on this site.
09/14/1995	SUPPL-8	Labeling		Label is not available on this site.
09/14/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/11/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/14/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/14/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 089074

STIE-CORT

LOTION;TOPICAL; 2.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE	HYDROCORTISONE	2.5%	LOTION;TOPICAL	Prescription	No	AT	040247	TARO
STIE-CORT	HYDROCORTISONE	2.5%	LOTION;TOPICAL	Prescription	No	AT	089074	PADAGIS US