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Details for New Drug Application (NDA): 076715

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NDA 076715 describes MODAFINIL, which is a drug marketed by Alembic 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. There are eight tentative approvals for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 076715

Watson Labs Inc
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 076715

Suppliers and Packaging for NDA: 076715

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 076715 ANDA Actavis Pharma, Inc. 0591-3499 0591-3499-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-3499-01)
TABLET;ORAL 076715 ANDA Actavis Pharma, Inc. 0591-3499 0591-3499-30 30 TABLET in 1 BOTTLE, PLASTIC (0591-3499-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 1, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 1, 2012TE: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.