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FDA ANDA · ANDA040001

METHAZOLAMIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA040001
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-30
LATEST ACTION
2002-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METHAZOLAMIDEPrescription
METHAZOLAMIDE 50MG · TABLET · ORAL
METHAZOLAMIDEPrescription
METHAZOLAMIDE 25MG · TABLET · ORAL

Approval history

2002-12-13Manufacturing (CMC) · Supplement 11AP
2001-11-26Manufacturing (CMC) · Supplement 10AP
2000-12-07Manufacturing (CMC) · Supplement 9AP
2000-12-07Manufacturing (CMC) · Supplement 7AP
2000-12-07Manufacturing (CMC) · Supplement 8AP
1999-05-13Manufacturing (CMC) · Supplement 5AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1998-12-07Manufacturing (CMC) · Supplement 4AP
1996-08-01Manufacturing (CMC) · Supplement 2AP
1993-06-30OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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