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FDA ANDA · ANDA081319

PYRAZINAMIDE

Sponsor: HIKMA

APPLICATION
ANDA081319
TYPE
ANDA
ORIGINAL APPROVAL
1992-06-30
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PYRAZINAMIDEPrescription
PYRAZINAMIDE 500MG · TABLET · ORAL

Approval history

2002-08-13Manufacturing (CMC) · Supplement 20AP
2001-05-29Manufacturing (CMC) · Supplement 19AP
2001-05-29Manufacturing (CMC) · Supplement 18AP
1998-07-31Manufacturing (CMC) · Supplement 17AP
1996-06-10Manufacturing (CMC) · Supplement 15AP
1996-06-10Manufacturing (CMC) · Supplement 16AP
1996-06-10Manufacturing (CMC) · Supplement 14AP
1995-02-08Manufacturing (CMC) · Supplement 12AP
1994-09-16Labeling · Supplement 11AP
1994-09-16Manufacturing (CMC) · Supplement 9AP
1994-09-16Manufacturing (CMC) · Supplement 10AP
1994-09-16Manufacturing (CMC) · Supplement 8AP
1994-02-28Manufacturing (CMC) · Supplement 4AP
1994-02-28Manufacturing (CMC) · Supplement 2AP
1994-02-28Manufacturing (CMC) · Supplement 7AP
1994-02-28Manufacturing (CMC) · Supplement 5AP
1994-02-28Labeling · Supplement 3AP
1994-02-28Labeling · Supplement 6AP
1992-11-16Manufacturing (CMC) · Supplement 1AP
1992-06-30OriginalAP
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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