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Last Updated: November 2, 2024

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-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:0
Pharmacology for NDA: 021777
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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Feb 1, 2007TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Feb 1, 2007TE:ABRLD:Yes

Expired US Patents for NDA 021777

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-001 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl AMRIX cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021777-002 Feb 1, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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