Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077090
Company: APOTEX INC
Company: APOTEX INC
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 |
---|---|---|---|---|---|---|---|
09/13/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077090ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/30/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/29/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
02/29/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
10/09/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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 |
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 |
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 |