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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Teva
Colorcon
Boehringer Ingelheim
Merck
Cipla
Cantor Fitzgerald
Medtronic
Moodys

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090374

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NDA 090374 describes ZALEPLON, which is a drug marketed by Cipla Ltd, Upsher-smith Labs, Aurobindo Pharma, West-ward Pharms Int, Mylan, Teva Pharms, Hikma Pharms, Orchid Hlthcare, and Unichem, and is included in ten NDAs. It is available from twenty-two suppliers. Additional details are available on the ZALEPLON profile page.

The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for NDA: 090374

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

Pharmacology for NDA: 090374

Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 090374

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON
zaleplon
CAPSULE;ORAL 090374 ANDA Northstar Rx LLC 16714-551 16714-551-02 100 CAPSULE in 1 BOTTLE (16714-551-02)
ZALEPLON
zaleplon
CAPSULE;ORAL 090374 ANDA Northstar Rx LLC 16714-561 16714-561-02 100 CAPSULE in 1 BOTTLE (16714-561-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Sep 17, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 17, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
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Citi
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Argus Health
Federal Trade Commission
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