Details for New Drug Application (NDA): 075141
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NDA 075141 describes ORPHENGESIC FORTE, which is a drug marketed by Galt Pharms and is included in one NDA. It is available from three suppliers. Additional details are available on the ORPHENGESIC FORTE profile page.
The generic ingredient in ORPHENGESIC FORTE 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 ORPHENGESIC FORTE 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 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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