Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089753
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Discontinued None No No
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription AB 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
06/22/1988 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
10/25/2001 SUPPL-10 Labeling

Label is not available on this site.

08/08/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/11/1992 SUPPL-2 Labeling

Label is not available on this site.

06/08/1990 SUPPL-1 Labeling

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

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