Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012828
Company: ABBOTT

Products on NDA 012828

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAVASE	SUTILAINS	82,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012828

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/1969	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/1995	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/1990	SUPPL-25	Labeling		Label is not available on this site.
01/19/1990	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/11/1988	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
07/24/1986	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/22/1982	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
06/20/1981	SUPPL-20	Labeling		Label is not available on this site.
05/01/1980	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
01/09/1980	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
12/10/1979	SUPPL-17	Labeling		Label is not available on this site.
10/16/1979	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
10/26/1978	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/26/1978	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1974	SUPPL-9			Label is not available on this site.