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Serving 500+ biopharmaceutical companies globally:

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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202566

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NDA 202566 describes MODAFINIL, which is a drug marketed by Alembic Pharms Ltd, Watson Labs Inc, Hikma Pharms, Orchid Hlthcare, Aurobindo Pharma Ltd, Apotex Inc, and Mylan Pharms Inc, and is included in seven NDAs. It is available from eighteen suppliers. Additional details are available on the MODAFINIL profile page.

The generic ingredient in MODAFINIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 202566

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202566

Suppliers and Packaging for NDA: 202566

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL
modafinil
TABLET;ORAL 202566 ANDA AvPAK 50268-570 50268-570-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-570-12) > 1 TABLET in 1 BLISTER PACK (50268-570-11)
MODAFINIL
modafinil
TABLET;ORAL 202566 ANDA AvPAK 50268-571 50268-571-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-571-12) > 1 TABLET in 1 BLISTER PACK (50268-571-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 27, 2012TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
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Harvard Business School
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Cipla
Covington

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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