Details for New Drug Application (NDA): 021777
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NDA 021777 describes AMRIX, which is a drug marketed by Teva Pharms Intl and is included in one NDA. It is available from nine suppliers. Additional details are available on the AMRIX profile page.
The generic ingredient in AMRIX is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
The generic ingredient in AMRIX is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 021777
| Tradename: | AMRIX |
| Applicant: | Teva Pharms Intl |
| Ingredient: | cyclobenzaprine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021777
| Physiological Effect | Centrally-mediated Muscle Relaxation |
Suppliers and Packaging for NDA: 021777
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMRIX | cyclobenzaprine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021777 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-1920 | 0093-1920-06 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1920-06) |
| AMRIX | cyclobenzaprine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021777 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-1921 | 0093-1921-06 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1921-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
| Approval Date: | Feb 1, 2007 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Feb 1, 2007 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021777
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