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FDA NDA · NDA013416

NORGESIC FORTE

Sponsor: BAUSCH

APPLICATION
NDA013416
TYPE
NDA
ORIGINAL APPROVAL
1964-03-04
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORGESIC FORTE · ReferenceDiscontinued
ASPIRIN 770MG, CAFFEINE 60MG, ORPHENADRINE CITRATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NORGESIC · ReferenceDiscontinued
ASPIRIN 385MG, CAFFEINE 30MG, ORPHENADRINE CITRATE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-04-28Labeling · Supplement 30 · standard — Letter ↗AP
2002-11-25Labeling · Supplement 21 — Letter ↗AP
1999-03-26Manufacturing (CMC) · Supplement 29 · standardAP
1997-09-12Manufacturing (CMC) · Supplement 28 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 27 · standardAP
1993-12-16Manufacturing (CMC) · Supplement 26 · standardAP
1993-11-05Manufacturing (CMC) · Supplement 23 · standardAP
1988-03-30Manufacturing (CMC) · Supplement 24 · standardAP
1987-04-28Manufacturing (CMC) · Supplement 22 · standardAP
1986-01-31Labeling · Supplement 20AP
1977-07-27Manufacturing (CMC) · Supplement 11 · standardAP
1977-07-27Manufacturing (CMC) · Supplement 12 · standardAP
1964-03-04Type 4 - New Combination · Original · standardAP
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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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