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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Boehringer Ingelheim
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202395

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NDA 202395 describes ZIPRASIDONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Wockhardt Ltd, Lupin Pharms, Apotex Inc, Sandoz Inc, Dr Reddys Labs Inc, Macleods Pharms Ltd, Zydus Pharms Usa Inc, and Mylan Pharms Inc, and is included in nine NDAs. It is available from twenty-seven suppliers. Additional details are available on the ZIPRASIDONE HYDROCHLORIDE profile page.

The generic ingredient in ZIPRASIDONE HYDROCHLORIDE is ziprasidone hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ziprasidone hydrochloride profile page.

Summary for NDA: 202395

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

Pharmacology for NDA: 202395

Suppliers and Packaging for NDA: 202395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL 202395 ANDA Mylan Pharmaceuticals Inc. 0378-7351 0378-7351-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-7351-05)
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride
CAPSULE;ORAL 202395 ANDA Mylan Pharmaceuticals Inc. 0378-7351 0378-7351-91 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-7351-91)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 20MG BASE
Approval Date:Oct 10, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Oct 10, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 60MG BASE
Approval Date:Oct 10, 2013TE:ABRLD:No


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