Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050505
Company: SCHERING
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GARAMYCIN GENTAMICIN SULFATE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRATHECAL Discontinued None Yes No
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.

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