Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050505
Company: SCHERING

Products on NDA 050505

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GARAMYCIN	GENTAMICIN SULFATE	EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INTRATHECAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050505

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/01/1979	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
10/21/1980	SUPPL-10	Labeling		Label is not available on this site.
03/18/1980	SUPPL-9	Labeling		Label is not available on this site.
02/14/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/20/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/17/1986	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/17/1983	SUPPL-4	Labeling		Label is not available on this site.
05/17/1983	SUPPL-3	Labeling		Label is not available on this site.
10/29/1982	SUPPL-1	Labeling		Label is not available on this site.