Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209504
Company: ANI PHARMS INC
Company: ANI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | AB | No | No |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | AB | No | No |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/30/2018 | 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 |
|---|---|---|---|---|---|
| 05/15/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
FENOFIBRATE (MICRONIZED)
CAPSULE;ORAL; 67MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 210705 | AJANTA PHARMA LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 213842 | ALEMBIC PHARMS LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 209504 | ANI PHARMS INC |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 207805 | AUSTARPHARMA |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 205566 | GLENMARK PHARMS LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 075868 | IMPAX LABS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 207378 | INVAGEN PHARMS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 202676 | MYLAN PHARMS INC |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 075753 | RHODES PHARMS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Prescription | No | AB | 210782 | TORRENT |
CAPSULE;ORAL; 134MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 210705 | AJANTA PHARMA LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 213842 | ALEMBIC PHARMS LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 209504 | ANI PHARMS INC |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 207805 | AUSTARPHARMA |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 205566 | GLENMARK PHARMS LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 075868 | IMPAX LABS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 207378 | INVAGEN PHARMS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 202676 | MYLAN PHARMS INC |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 075753 | RHODES PHARMS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Prescription | No | AB | 210782 | TORRENT |
CAPSULE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 210705 | AJANTA PHARMA LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 213842 | ALEMBIC PHARMS LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 209504 | ANI PHARMS INC |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207805 | AUSTARPHARMA |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 205566 | GLENMARK PHARMS LTD |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075868 | IMPAX LABS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 207378 | INVAGEN PHARMS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 202676 | MYLAN PHARMS INC |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 075753 | RHODES PHARMS |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Prescription | No | AB | 210782 | TORRENT |
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