Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050039
Company: SCHERING
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GARAMYCIN GENTAMICIN SULFATE EQ 0.3% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No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
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.

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