Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207438
Company: BAUSCH
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
10/05/2018 ORIG-1 Approval STANDARD

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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