Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088450
Company: WOCKHARDT BIO AG

Products on ANDA 088450

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	LOTION;TOPICAL	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088450

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/1985	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
11/10/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/01/1996	SUPPL-11	Labeling		Label is not available on this site.
08/01/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/01/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/27/1993	SUPPL-8	Labeling		Label is not available on this site.
02/21/1992	SUPPL-7	Labeling		Label is not available on this site.
05/11/1989	SUPPL-6	Labeling		Label is not available on this site.
05/29/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088450

TRIAMCINOLONE ACETONIDE

LOTION;TOPICAL; 0.025%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	LOTION;TOPICAL	Prescription	No	AT	202374	EPIC PHARMA LLC
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	LOTION;TOPICAL	Prescription	No	AT	040467	FOUGERA PHARMS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	LOTION;TOPICAL	Prescription	No	AT	213559	QUAGEN
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	LOTION;TOPICAL	Prescription	No	AT	088450	WOCKHARDT BIO AG