Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062347
Company: TARO

Products on ANDA 062347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NYSTATIN AND TRIAMCINOLONE ACETONIDE	NYSTATIN; TRIAMCINOLONE ACETONIDE	100,000 UNITS/GM;0.1%	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/1987	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
04/29/1993	SUPPL-25	Labeling		Label is not available on this site.
04/29/1993	SUPPL-24	Labeling		Label is not available on this site.
11/25/1992	SUPPL-22	Labeling		Label is not available on this site.
11/25/1992	SUPPL-21	Labeling		Label is not available on this site.
02/20/1992	SUPPL-20	Labeling		Label is not available on this site.
07/31/1991	SUPPL-19	Labeling		Label is not available on this site.
12/31/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/31/1991	SUPPL-15	Labeling		Label is not available on this site.
07/31/1991	SUPPL-14	Labeling		Label is not available on this site.
06/30/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/24/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/24/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/10/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/15/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.