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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212308
Company: ZYDUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription AB No No
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/24/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212308Orig1s000ltr.pdf

LEFLUNOMIDE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARAVA LEFLUNOMIDE 10MG TABLET;ORAL Prescription Yes AB 020905 SANOFI AVENTIS US
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 212453 ABHAI LLC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 213497 AET PHARMA
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 213652 AUROBINDO PHARMA LTD
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 211863 LUPIN LTD
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 077087 WANBANG BIOPHARMS
LEFLUNOMIDE LEFLUNOMIDE 10MG TABLET;ORAL Prescription No AB 212308 ZYDUS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARAVA LEFLUNOMIDE 20MG TABLET;ORAL Prescription Yes AB 020905 SANOFI AVENTIS US
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 212453 ABHAI LLC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 213497 AET PHARMA
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 091369 ALEMBIC PHARMS LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077090 APOTEX INC
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 213652 AUROBINDO PHARMA LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077086 HERITAGE PHARMS
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 211863 LUPIN LTD
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 077087 WANBANG BIOPHARMS
LEFLUNOMIDE LEFLUNOMIDE 20MG TABLET;ORAL Prescription No AB 212308 ZYDUS
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