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Details for New Drug Application (NDA): 075713

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NDA 075713 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, Teva Pharms Usa, Sandoz, Par Pharm, and Accord Hlthcare, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the CLOZAPINE profile page.

The generic ingredient in CLOZAPINE is clozapine. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the clozapine profile page.

Summary for NDA: 075713

Tradename:
CLOZAPINE
Applicant:
Sun Pharm Inds Inc
Ingredient:
clozapine
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075713

Suppliers and Packaging for NDA: 075713

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOZAPINE
clozapine
TABLET;ORAL 075713 ANDA Sun Pharmaceutical Industries, Inc. 57664-241 57664-241-13 500 TABLET in 1 BOTTLE (57664-241-13)
CLOZAPINE
clozapine
TABLET;ORAL 075713 ANDA Sun Pharmaceutical Industries, Inc. 57664-241 57664-241-88 100 TABLET in 1 BOTTLE (57664-241-88)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 15, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 15, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 19, 2005TE:ABRLD:No


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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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