Details for New Drug Application (NDA): 075141
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The generic ingredient in ORPHENGESIC FORTE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
Summary for 075141
Tradename: | ORPHENGESIC FORTE |
Applicant: | Galt Pharms |
Ingredient: | aspirin; caffeine; orphenadrine citrate |
Patents: | 0 |
Pharmacology for NDA: 075141
Mechanism of Action | Cyclooxygenase Inhibitors |
Physiological Effect | Central Nervous System Stimulation Centrally-mediated Muscle Relaxation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 075141
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ORPHENGESIC | aspirin; caffeine; orphenadrine citrate | TABLET;ORAL | 075141 | ANDA | Poly Pharmaceuticals, Inc. | 50991-999 | 50991-999-06 | 6 TABLET, MULTILAYER in 1 CARTON (50991-999-06) |
ORPHENGESIC | aspirin; caffeine; orphenadrine citrate | TABLET;ORAL | 075141 | ANDA | Poly Pharmaceuticals, Inc. | 50991-999 | 50991-999-60 | 60 TABLET, MULTILAYER in 1 BOTTLE (50991-999-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 385MG;30MG;25MG | ||||
Approval Date: | May 29, 1998 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 770MG;60MG;50MG | ||||
Approval Date: | May 29, 1998 | TE: | RLD: | No |
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