Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011600
Company: MYLAN

Products on NDA 011600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/1963	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/1996	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
07/09/1993	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/04/1987	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf
08/09/1984	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/08/1984	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
08/10/1983	SUPPL-23	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/26/1981	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
12/13/1982	SUPPL-21	Labeling		Label is not available on this site.
07/05/1978	SUPPL-20	Labeling		Label is not available on this site.
01/23/1980	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
10/11/1977	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
10/11/1977	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
06/17/1977	SUPPL-16	Labeling		Label is not available on this site.
02/04/1977	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/15/1976	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/11/1975	SUPPL-12	Labeling		Label is not available on this site.
07/08/1974	SUPPL-10			Label is not available on this site.

Labels for NDA 011600

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/1987	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/011600s026lbl.pdf