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Details for New Drug Application (NDA): 201824

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NDA 201824 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 ten 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. Fourteen 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: 201824

Mylan Pharms Inc
Therapeutic Class:Antipsychotics

Pharmacology for NDA: 201824

Suppliers and Packaging for NDA: 201824

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, ORALLY DISINTEGRATING;ORAL 201824 ANDA Mylan Pharmaceuticals Inc. 0378-3813 0378-3813-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01)
TABLET, ORALLY DISINTEGRATING;ORAL 201824 ANDA Mylan Pharmaceuticals Inc. 0378-3813 0378-3813-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-05)

Summary for product number 002

Approval Date:Sep 15, 2015TE:ABRLD:No

Summary for product number 003

Approval Date:Sep 15, 2015TE: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.