Details for New Drug Application (NDA): 081145
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NDA 081145 describes METHOCARBAMOL AND ASPIRIN, which is a drug marketed by Ivax Sub Teva Pharms, Mcneil, Par Pharm, and Stevens J, and is included in four NDAs. It is available from one supplier. Additional details are available on the METHOCARBAMOL AND ASPIRIN profile page.
The generic ingredient in METHOCARBAMOL AND ASPIRIN is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; methocarbamol profile page.
The generic ingredient in METHOCARBAMOL AND ASPIRIN is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; methocarbamol profile page.
Summary for 081145
| Tradename: | METHOCARBAMOL AND ASPIRIN |
| Applicant: | Stevens J |
| Ingredient: | aspirin; methocarbamol |
| Patents: | 0 |
Pharmacology for NDA: 081145
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Centrally-mediated Muscle Relaxation Decreased Platelet Aggregation Decreased Prostaglandin Production |
Suppliers and Packaging for NDA: 081145
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHOCARBAMOL AND ASPIRIN | aspirin; methocarbamol | TABLET;ORAL | 081145 | ANDA | Jerome Stevens Pharmaceuticals, Inc. | 50564-490 | 50564-490-01 | 100 TABLET in 1 BOTTLE (50564-490-01) |
| METHOCARBAMOL AND ASPIRIN | aspirin; methocarbamol | TABLET;ORAL | 081145 | ANDA | Jerome Stevens Pharmaceuticals, Inc. | 50564-490 | 50564-490-05 | 500 TABLET in 1 BOTTLE (50564-490-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;400MG | ||||
| Approval Date: | Jan 31, 1995 | TE: | RLD: | No | |||||
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