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Generated: April 21, 2019

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Details for New Drug Application (NDA): 020989

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NDA 020989 describes EVOXAC, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from two 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. Five suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.
Summary for 020989
Tradename:EVOXAC
Applicant:Daiichi Sankyo Inc
Ingredient:cevimeline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020989
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 Sun Pharmaceutical Industries, Inc. 63304-479 63304-479-01 100 CAPSULE in 1 BOTTLE (63304-479-01)
EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989 NDA Daiichi Sankyo, Inc. 63395-201 63395-201-13 100 CAPSULE in 1 BOTTLE, PLASTIC (63395-201-13)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jan 11, 2000TE:ABRLD:Yes

Expired US Patents for NDA 020989

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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