Details for New Drug Application (NDA): 074988
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NDA 074988 describes ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, which is a drug marketed by Sandoz and Stevens J and is included in two NDAs. It is available from one supplier. Additional details are available on the ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE profile page.
The generic ingredient in ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
The generic ingredient in ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE is aspirin; caffeine; orphenadrine citrate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; caffeine; orphenadrine citrate profile page.
Summary for 074988
| Tradename: | ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE |
| Applicant: | Stevens J |
| Ingredient: | aspirin; caffeine; orphenadrine citrate |
| Patents: | 0 |
Pharmacology for NDA: 074988
| 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: 074988
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE | aspirin; caffeine; orphenadrine citrate | TABLET;ORAL | 074988 | ANDA | Jerome Stevens Pharmaceuticals, Inc. | 50564-554 | 50564-554-01 | 100 TABLET in 1 BOTTLE (50564-554-01) |
| ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE | aspirin; caffeine; orphenadrine citrate | TABLET;ORAL | 074988 | ANDA | Jerome Stevens Pharmaceuticals, Inc. | 50564-554 | 50564-554-05 | 500 TABLET in 1 BOTTLE (50564-554-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 385MG;30MG;25MG | ||||
| Approval Date: | Apr 30, 1999 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 770MG;60MG;50MG | ||||
| Approval Date: | Apr 30, 1999 | TE: | RLD: | No | |||||
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