You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 23, 2024

Details for New Drug Application (NDA): 077667


✉ Email this page to a colleague

« Back to Dashboard


NDA 077667 describes MODAFINIL, which is a drug marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, Orbion Pharms, and Watson Labs Inc, and is included in nine 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 suppliers are listed for this compound. Additional details are available on the modafinil profile page.
Summary for 077667
Tradename:MODAFINIL
Applicant:Apotex
Ingredient:modafinil
Patents:0
Pharmacology for NDA: 077667
Suppliers and Packaging for NDA: 077667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MODAFINIL modafinil TABLET;ORAL 077667 ANDA Major Pharmaceuticals 0904-6791 0904-6791-04 30 BLISTER PACK in 1 CARTON (0904-6791-04) / 1 TABLET in 1 BLISTER PACK
MODAFINIL modafinil TABLET;ORAL 077667 ANDA Major Pharmaceuticals 0904-6792 0904-6792-04 30 BLISTER PACK in 1 CARTON (0904-6792-04) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Feb 3, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 3, 2014TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.