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LEFLUNOMIDE

ANDA

LEFLUNOMIDE | A077084 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI GERMANY GMBHLEFLUNOMIDE

DMF 81161989

FORMOSA LABORATORIES INCLEFLUNOMIDE

DMF 160382002

CIPLA LTDLEFLUNOMIDE USP

DMF 161092002

ALEMBIC PHARMACEUTICALS LTDLEFLUNOMIDE USP

DMF 161122002

EMCURE PHARMACEUTICALS LTDLEFLUNOMIDE USP

DMF 161242002

MAPRIMED SALEFLUNOMIDE

DMF 329882018

UNICHEM LABORATORIES LTDInactiveLEFLUNOMIDE

DMF 165042003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 15, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 13, 2005

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 13, 2005