Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062307
Company: PERRIGO NEW YORK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE CREAM;TOPICAL Prescription AT No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/15/1981 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
12/03/2009 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

04/17/2009 SUPPL-21 Labeling

Label is not available on this site.

05/09/2003 SUPPL-18 Labeling

Label is not available on this site.

09/18/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1993 SUPPL-15 Labeling

Label is not available on this site.

GENTAMICIN SULFATE

CREAM;TOPICAL; EQ 0.1% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AT 064056 ACP NIMBLE
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AT 062307 PERRIGO NEW YORK

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