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FDA ANDA · ANDA080157

PYRAZINAMIDE

Sponsor: NOVITIUM PHARMA

APPLICATION
ANDA080157
TYPE
ANDA
ORIGINAL APPROVAL
1971-06-03
LATEST ACTION
2001-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PYRAZINAMIDE · ReferencePrescription
PYRAZINAMIDE 500MG · TABLET · ORAL

Approval history

2001-02-28Manufacturing (CMC) · Supplement 17AP
2001-02-28Manufacturing (CMC) · Supplement 18AP
2001-02-28Manufacturing (CMC) · Supplement 16AP
1999-03-03Manufacturing (CMC) · Supplement 15AP
1994-05-23Labeling · Supplement 14AP
1994-05-16Manufacturing (CMC) · Supplement 13AP
1992-04-20Labeling · Supplement 11AP
1992-04-20Labeling · Supplement 36AP
1991-10-22Manufacturing (CMC) · Supplement 10AP
1990-10-04Labeling · Supplement 9AP
1987-10-19Manufacturing (CMC) · Supplement 8AP
1982-08-10Manufacturing (CMC) · Supplement 6AP
1971-06-03OriginalAP
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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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