Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040036
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription AB No No
METHAZOLAMIDE METHAZOLAMIDE 50MG 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
06/30/1993 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
03/25/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/10/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METHAZOLAMIDE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 040001 ANI PHARMS
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 207438 BAUSCH
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 040062 MIKART
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 040036 SANDOZ

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 040001 ANI PHARMS
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 207438 BAUSCH
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 040062 MIKART
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 040036 SANDOZ

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