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Serving leading biopharmaceutical companies globally:

Dow
Teva
Farmers Insurance
Julphar
Johnson and Johnson
Healthtrust
Colorcon
Argus Health
Fish and Richardson
UBS

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090308

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NDA 090308 describes CLOZAPINE, which is a drug marketed by Mayne Pharma, Barr Labs Inc, Ivax Sub Teva Pharms, Sun Pharm Inds Inc, Mylan, Mylan Pharms Inc, Aurobindo Pharma Ltd, Teva Pharms Usa, Sandoz, Par Pharm, and Accord Hlthcare, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 090308

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 090308

Suppliers and Packaging for NDA: 090308

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL 090308 ANDA Teva Pharmaceuticals USA, Inc. 0093-5417 0093-5417-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5417-01)
CLOZAPINE
clozapine
TABLET, ORALLY DISINTEGRATING;ORAL 090308 ANDA Teva Pharmaceuticals USA, Inc. 0093-5417 0093-5417-84 48 BLISTER PACK in 1 CARTON (0093-5417-84) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5417-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG
Approval Date:Nov 25, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength100MG
Approval Date:Nov 25, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
US Army
Cipla
Moodys
Citi
Julphar
Cerilliant
Fuji
Accenture
Mallinckrodt

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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