APPLICATION
ANDA084840
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-31
LATEST ACTION
2016-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACETAZOLAMIDEPrescription
ACETAZOLAMIDE 250MG · TABLET · ORAL
Approval history
2016-10-24Manufacturing (CMC) · Supplement 26 · unknownAP
2008-05-29Labeling · Supplement 23AP
2001-12-12Labeling · Supplement 19AP
2000-08-10Manufacturing (CMC) · Supplement 18AP
1996-07-26Labeling · Supplement 16AP
1996-07-26Manufacturing (CMC) · Supplement 14AP
1996-07-26Manufacturing (CMC) · Supplement 17AP
1996-07-26Manufacturing (CMC) · Supplement 15AP
1996-07-26Manufacturing (CMC) · Supplement 13AP
1994-06-27Manufacturing (CMC) · Supplement 7AP
1990-06-05Labeling · Supplement 11AP
1988-05-04Labeling · Supplement 8AP
1981-11-16Manufacturing (CMC) · Supplement 3AP
1978-03-31OriginalAP
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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