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LEFLUNOMIDE

ANDA

LEFLUNOMIDE | A212308 | ZYDUS LIFESCIENCES GLOBAL FZE

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ARAVA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$0.3247

per ea

Lowest NADAC/Unit

$0.2917

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70710115703LEFLUNOMIDE 10 MG TABLET	$0.3247	EA	Generic	—	2026-08-19
70710115803LEFLUNOMIDE 20 MG TABLET	$0.2917	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

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
Apr 26, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 24, 2019

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 24, 2019