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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040001
Company: ANI PHARMS

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
12/13/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
11/26/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.
12/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.
12/07/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.
12/07/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
03/23/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
05/13/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
12/07/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
08/01/1996 SUPPL-2 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 AND LOMB INC
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 040062 MIKART
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 040036 SANDOZ
METHAZOLAMIDE METHAZOLAMIDE 25MG TABLET;ORAL Prescription No AB 215615 TAGI

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 AND LOMB INC
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 040062 MIKART
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 040036 SANDOZ
METHAZOLAMIDE METHAZOLAMIDE 50MG TABLET;ORAL Prescription No AB 215615 TAGI
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