Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076635
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
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 | Prescription | 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 |
---|---|---|---|---|---|---|---|
10/31/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076635ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/03/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
10/13/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
10/13/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
10/13/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
05/18/2018 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |