APPLICATION
ANDA074654
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINEDiscontinued
ASPIRIN 385MG, CAFFEINE 30MG, ORPHENADRINE CITRATE 25MG · TABLET · ORAL
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINEDiscontinued
ASPIRIN 770MG, CAFFEINE 60MG, ORPHENADRINE CITRATE 50MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 21 · standardAP
2024-09-30Labeling · Supplement 20 · standardAP
2021-04-28Labeling · Supplement 19 · standardAP
2000-09-13Manufacturing (CMC) · Supplement 4AP
2000-02-02Manufacturing (CMC) · Supplement 3AP
1999-09-14Manufacturing (CMC) · Supplement 2AP
1999-01-08Manufacturing (CMC) · Supplement 1AP
1996-12-31OriginalAP
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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