Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209710
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | AB | No | No |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | 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 |
---|---|---|---|---|---|---|---|
01/03/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/04/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
03/07/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/07/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/19/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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08/19/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
TERIFLUNOMIDE
TABLET;ORAL; 7MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AUBAGIO | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | Yes | AB | 202992 | SANOFI AVENTIS US |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209690 | ACCORD HLTHCARE |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209572 | ALEMBIC |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209601 | APOTEX |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209638 | AUROBINDO PHARMA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209639 | BIOCON PHARMA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209663 | GLENMARK SPECLT |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209598 | HETERO LABS LTD V |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209623 | MSN |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209555 | NATCO |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209710 | SANDOZ |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209677 | SOLA PHARMS |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209700 | TEVA PHARMS USA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209697 | TORRENT |
TERIFLUNOMIDE | TERIFLUNOMIDE | 7MG | TABLET;ORAL | Prescription | No | AB | 209668 | ZYDUS PHARMS |
TABLET;ORAL; 14MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AUBAGIO | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | Yes | AB | 202992 | SANOFI AVENTIS US |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209690 | ACCORD HLTHCARE |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209572 | ALEMBIC |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209601 | APOTEX |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209638 | AUROBINDO PHARMA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209639 | BIOCON PHARMA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209663 | GLENMARK SPECLT |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209598 | HETERO LABS LTD V |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209623 | MSN |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209555 | NATCO |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209710 | SANDOZ |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209677 | SOLA PHARMS |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209700 | TEVA PHARMS USA |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209697 | TORRENT |
TERIFLUNOMIDE | TERIFLUNOMIDE | 14MG | TABLET;ORAL | Prescription | No | AB | 209668 | ZYDUS PHARMS |