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.

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