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Serving leading biopharmaceutical companies globally:

Chubb
Johnson and Johnson
Daiichi Sankyo
Boehringer Ingelheim
Farmers Insurance
Cipla
Covington
Medtronic
Teva
Moodys

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091260

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NDA 091260 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Novel Labs Inc, Apotex Inc, Rising Pharms Inc, and West-ward Pharms Int, and is included in four NDAs. It is available from five suppliers. Additional details are available on the CEVIMELINE HYDROCHLORIDE profile page.

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

Summary for 091260

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091260

Suppliers and Packaging for NDA: 091260

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride
CAPSULE;ORAL 091260 ANDA Apotex Corp. 60505-3145 60505-3145-1 100 CAPSULE in 1 BOTTLE (60505-3145-1)
CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride
CAPSULE;ORAL 091260 ANDA Apotex Corp. 60505-3145 60505-3145-5 500 CAPSULE in 1 BOTTLE (60505-3145-5)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Aug 25, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Teva
Merck
Healthtrust
Mallinckrodt
Argus Health
Express Scripts
Cerilliant
Fuji
Colorcon
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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