Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050039
Company: SCHERING

Products on NDA 050039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GARAMYCIN	GENTAMICIN SULFATE	EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/1970	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
10/18/1999	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
09/20/1999	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1999	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/1997	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
07/29/1997	SUPPL-16	Labeling		Label is not available on this site.
11/13/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/13/1981	SUPPL-14	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/24/1981	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/24/1980	SUPPL-12	Labeling		Label is not available on this site.
09/18/1979	SUPPL-11	Labeling		Label is not available on this site.
01/25/1979	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/1974	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/11/1972	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/17/1992	SUPPL-6	Labeling		Label is not available on this site.
02/14/1989	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/20/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/12/1986	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/15/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.