APPLICATION
ANDA074817
TYPE
ANDA
ORIGINAL APPROVAL
1996-11-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
INVAGESICDiscontinued
ASPIRIN 385MG, CAFFEINE 30MG, ORPHENADRINE CITRATE 25MG · TABLET · ORAL
INVAGESIC FORTEDiscontinued
ASPIRIN 770MG, CAFFEINE 60MG, ORPHENADRINE CITRATE 50MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 6 · standardAP
2024-10-11Labeling · Supplement 5 · standardAP
2021-04-28Labeling · Supplement 3 · standardAP
1998-08-19Manufacturing (CMC) · Supplement 2AP
1997-08-06Manufacturing (CMC) · Supplement 1AP
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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