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FDA NDA · NDA050429

RIMACTANE

Sponsor: OXFORD PHARMS

APPLICATION
NDA050429
TYPE
NDA
ORIGINAL APPROVAL
1971-05-21
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RIMACTANEPrescription
RIFAMPIN 300MG · CAPSULE · ORAL

Approval history

2023-08-16Labeling · Supplement 87 · standard — Letter ↗AP
2019-01-23Labeling · Supplement 86 · standard — Label ↗AP
2004-11-18Labeling · Supplement 83 · standard — Letter ↗AP
2001-03-01Manufacturing (CMC) · Supplement 81AP
2000-05-26Manufacturing (CMC) · Supplement 79AP
2000-05-26Manufacturing (CMC) · Supplement 80AP
1999-02-18Manufacturing (CMC) · Supplement 78AP
1998-10-30Manufacturing (CMC) · Supplement 77AP
1998-08-14Manufacturing (CMC) · Supplement 76AP
1997-04-07Manufacturing (CMC) · Supplement 75AP
1996-03-04Manufacturing (CMC) · Supplement 74AP
1995-03-27Manufacturing (CMC) · Supplement 73AP
1994-07-29Manufacturing (CMC) · Supplement 71AP
1994-06-06Manufacturing (CMC) · Supplement 72AP
1992-09-23Manufacturing (CMC) · Supplement 70AP
1992-08-24Manufacturing (CMC) · Supplement 69AP
1992-08-24Manufacturing (CMC) · Supplement 68AP
1992-08-24Manufacturing (CMC) · Supplement 66AP
1991-05-31Manufacturing (CMC) · Supplement 67AP
1990-02-23Manufacturing (CMC) · Supplement 12AP
1989-07-21Labeling · Supplement 11AP
1988-11-29Manufacturing (CMC) · Supplement 9AP
1988-11-29Manufacturing (CMC) · Supplement 10AP
1985-10-07Labeling · Supplement 8AP
1985-07-08Manufacturing (CMC) · Supplement 7AP
1985-05-29Manufacturing (CMC) · Supplement 6AP
1985-04-03Manufacturing (CMC) · Supplement 5AP
1984-09-25Manufacturing (CMC) · Supplement 4AP
1983-11-29Manufacturing (CMC) · Supplement 3AP
1983-09-13Manufacturing (CMC) · Supplement 2AP
1982-12-06Manufacturing (CMC) · Supplement 1AP
1982-09-28Manufacturing (CMC) · Supplement 65AP
1982-06-17Manufacturing (CMC) · Supplement 64AP
1981-12-10Manufacturing (CMC) · Supplement 63AP
1981-03-23Manufacturing (CMC) · Supplement 62AP
1980-07-02Manufacturing (CMC) · Supplement 61AP
1979-10-29Manufacturing (CMC) · Supplement 60AP
1979-08-21Manufacturing (CMC) · Supplement 59AP
1979-04-13Manufacturing (CMC) · Supplement 58AP
1979-01-22Manufacturing (CMC) · Supplement 57AP
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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