Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209233
Company: PAI HOLDINGS PHARM
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
12/31/2018 ORIG-1 Approval STANDARD

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 COSETTE PHARMS
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 PADAGIS US
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AT 209233 PAI HOLDINGS PHARM
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AT 062477 TARO

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