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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 Alembic Pharms Ltd, Barr, Teva Pharms, Sandoz, Heritage Pharms Inc, and Apotex Inc, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the LEFLUNOMIDE profile page.

The generic ingredient in LEFLUNOMIDE is leflunomide. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

Summary for NDA: 077090

Tradename:
LEFLUNOMIDE
Applicant:
Apotex Inc
Ingredient:
leflunomide
Patents:0
Therapeutic Class:Immunological Agents
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 Golden State Medical Supply, Inc. 60429-319 60429-319-30 30 TABLET in 1 BOTTLE (60429-319-30)
LEFLUNOMIDE
leflunomide
TABLET;ORAL 077090 ANDA Golden State Medical Supply, Inc. 60429-320 60429-320-30 30 TABLET in 1 BOTTLE (60429-320-30)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 13, 2005TE: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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