Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062533
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription AT 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
10/05/1984 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
10/29/2004 SUPPL-6 Labeling

Label is not available on this site.

03/19/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/02/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/26/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

GENTAMICIN SULFATE

OINTMENT;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 OINTMENT;TOPICAL Prescription No AT 064054 ACP NIMBLE
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AT 062533 FOUGERA PHARMS INC
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AT 062351 PERRIGO NEW YORK
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AT 062477 TARO
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AT 209233 TELIGENT PHARMA INC

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