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FDA ANDA · ANDA075141
NORGESIC
orphenadrine citrate, aspirin and caffeine
Sponsor: GALT PHARMS
APPLICATION
ANDA075141
TYPE
ANDA
ORIGINAL APPROVAL
1998-05-29
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ORPHENGESICPrescription
ASPIRIN 385MG, CAFFEINE 30MG, ORPHENADRINE CITRATE 25MG · TABLET · ORAL
ORPHENGESIC FORTEPrescription
ASPIRIN 770MG, CAFFEINE 60MG, ORPHENADRINE CITRATE 50MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 4 · standardAP
2021-04-28Labeling · Supplement 2 · standardAP
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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