Details for New Drug Application (NDA): 020989

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NDA 020989 describes EVOXAC, which is a drug marketed by Cosette and is included in one NDA. It is available from three suppliers. Additional details are available on the EVOXAC profile page.

The generic ingredient in EVOXAC is cevimeline hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

Summary for 020989

Tradename:	EVOXAC
Applicant:	Cosette
Ingredient:	cevimeline hydrochloride
Patents:	0

Pharmacology for NDA: 020989

Mechanism of Action	Cholinergic Muscarinic Agonists

Suppliers and Packaging for NDA: 020989

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989	NDA	Cosette Pharmaceuticals, Inc.	0713-0883	0713-0883-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0883-01)
EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989	NDA	Cosette Pharmaceuticals, Inc.	0713-0937	0713-0937-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Jan 11, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020989

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	⤷ Sign Up	⤷ Sign Up
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	⤷ Sign Up	⤷ Sign Up
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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