Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062251
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Discontinued None No 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
06/05/1980 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
07/23/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

07/23/2001 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/14/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/03/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/16/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/18/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/17/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/08/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/22/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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