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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091153

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NDA 091153 describes ESZOPICLONE, which is a drug marketed by Sun Pharma Global, Orchid Hlthcare, Dr Reddys Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Mylan Pharms Inc, West-ward Pharms Int, Wockhardt Ltd, Glenmark Generics, and Teva, and is included in eleven NDAs. It is available from thirty-one suppliers. Additional details are available on the ESZOPICLONE profile page.

The generic ingredient in ESZOPICLONE is eszopiclone. There are twenty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

Summary for NDA: 091153

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

Suppliers and Packaging for NDA: 091153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESZOPICLONE
eszopiclone
TABLET;ORAL 091153 ANDA West-Ward Pharmaceuticals Corp. 0054-0290 0054-0290-13 30 TABLET in 1 BOTTLE (0054-0290-13)
ESZOPICLONE
eszopiclone
TABLET;ORAL 091153 ANDA West-Ward Pharmaceuticals Corp. 0054-0291 0054-0291-25 100 TABLET in 1 BOTTLE (0054-0291-25)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 15, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 15, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Apr 15, 2014TE: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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