Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040195
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription AB No No
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription AB 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
05/28/1997 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
01/09/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

ACETAZOLAMIDE

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 205530 HERITAGE PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 209734 STRIDES PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 089753 SUN PHARM INDUSTRIES
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 040195 TARO

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 205530 HERITAGE PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 084840 LANNETT
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 209734 STRIDES PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 040195 TARO

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