Details for New Drug Application (NDA): 021777
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
NDA 021777 describes AMRIX, which is a drug marketed by Teva Pharms Intl and is included in one NDA. It is available from seven suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. 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-six 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-six 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: | 8 |
| Formulation / Manufacturing: | see details |
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 | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 26, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 14, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | RELIEF OF MUSCLE SPASM | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 14, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
