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Cantor Fitzgerald
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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078829

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NDA 078829 describes ZALEPLON, which is a drug marketed by Cipla Ltd, Upsher-smith Labs, Aurobindo Pharma, West-ward Pharms Int, Mylan, Teva Pharms, Hikma Pharms Llc, Orchid Hlthcare, and Unichem, and is included in ten NDAs. It is available from twenty 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-three suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for NDA: 078829

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

Pharmacology for NDA: 078829

Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 078829

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZALEPLON
zaleplon
CAPSULE;ORAL 078829 ANDA PD-Rx Pharmaceuticals, Inc. 43063-505 43063-505-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30)
ZALEPLON
zaleplon
CAPSULE;ORAL 078829 ANDA Physicians Total Care, Inc. 54868-5908 54868-5908-0 10 CAPSULE in 1 BOTTLE (54868-5908-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 6, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 6, 2008TE:ABRLD:No


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Fuji
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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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