Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062427
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE CREAM;TOPICAL 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
05/26/1983 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
07/05/1996 SUPPL-39 Labeling

Label is not available on this site.

07/05/1996 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/16/1992 SUPPL-37 Labeling

Label is not available on this site.

08/27/1992 SUPPL-36 Labeling

Label is not available on this site.

06/26/1992 SUPPL-34 Labeling

Label is not available on this site.

04/22/1992 SUPPL-33 Labeling

Label is not available on this site.

04/26/1991 SUPPL-32 Labeling

Label is not available on this site.

07/30/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-29 Labeling

Label is not available on this site.

07/24/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-27 Labeling

Label is not available on this site.

11/16/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/09/1987 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/03/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/14/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/10/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/25/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/16/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

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