Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | AB | No | No |
FENOFIBRATE | FENOFIBRATE | 107MG | TABLET;ORAL | Discontinued | None | No | No |
FENOFIBRATE | FENOFIBRATE | 160MG | 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 |
---|---|---|---|---|---|---|---|
12/29/2005 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/03/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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09/23/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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09/23/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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09/23/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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09/23/2019 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/23/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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02/14/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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11/22/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/02/2010 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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05/03/2010 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/25/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
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10/25/2007 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
FENOFIBRATE
TABLET;ORAL; 54MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 210138 | AJANTA PHARMA LTD |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 209950 | AMNEAL |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 216798 | AUROBINDO PHARMA |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 207803 | AUSTARPHARMA |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 209660 | CHARTWELL RX |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 210670 | DR REDDYS |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 076509 | IMPAX LABS |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 204019 | LUPIN LTD |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 213864 | MANKIND PHARMA |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 076520 | MYLAN |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 076433 | RHODES PHARMS |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 210606 | RISING PHARMA |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 076635 | SUN PHARM INDS LTD |
FENOFIBRATE | FENOFIBRATE | 54MG | TABLET;ORAL | Prescription | No | AB | 218548 | YICHANG HUMANWELL |
TABLET;ORAL; 160MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 210138 | AJANTA PHARMA LTD |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 209950 | AMNEAL |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 216798 | AUROBINDO PHARMA |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 207803 | AUSTARPHARMA |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 209660 | CHARTWELL RX |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 210670 | DR REDDYS |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 076509 | IMPAX LABS |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 204019 | LUPIN LTD |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 213864 | MANKIND PHARMA |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 076520 | MYLAN |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 076433 | RHODES PHARMS |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 210606 | RISING PHARMA |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 076635 | SUN PHARM INDS LTD |
FENOFIBRATE | FENOFIBRATE | 160MG | TABLET;ORAL | Prescription | No | AB | 218548 | YICHANG HUMANWELL |