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Last Updated: August 2, 2021

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Details for New Drug Application (NDA): 077090

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NDA 077090 describes LEFLUNOMIDE, which is a drug marketed by Abhai Llc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Axunio, Barr, Fosun Pharma, Heritage Pharms Inc, Lupin Ltd, Sandoz, Teva Pharms, and Zydus, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the LEFLUNOMIDE profile page.

The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 077090
Applicant:Apotex Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 077090
Suppliers and Packaging for NDA: 077090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEFLUNOMIDE leflunomide TABLET;ORAL 077090 ANDA AvKARE 42291-420 42291-420-30 30 TABLET in 1 BOTTLE (42291-420-30)
LEFLUNOMIDE leflunomide TABLET;ORAL 077090 ANDA AvKARE 42291-421 42291-421-30 30 TABLET in 1 BOTTLE (42291-421-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 13, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 13, 2005TE:ABRLD:No

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