Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201748
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 | 43MG | CAPSULE;ORAL | Prescription | AB | No | No |
FENOFIBRATE | FENOFIBRATE | 130MG | 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 |
---|---|---|---|---|---|---|---|
10/31/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/25/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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08/25/2020 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
FENOFIBRATE
CAPSULE;ORAL; 43MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ANTARA (MICRONIZED) | FENOFIBRATE | 43MG | CAPSULE;ORAL | Prescription | Yes | AB | 021695 | LUPIN |
FENOFIBRATE | FENOFIBRATE | 43MG | CAPSULE;ORAL | Prescription | No | AB | 201748 | SUN PHARM INDS LTD |
FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 43MG | CAPSULE;ORAL | Prescription | No | AB | 202252 | APOTEX |
FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 43MG | CAPSULE;ORAL | Prescription | No | AB | 090859 | DR REDDYS LABS SA |
CAPSULE;ORAL; 130MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ANTARA (MICRONIZED) | FENOFIBRATE | 130MG | CAPSULE;ORAL | Prescription | Yes | AB | 021695 | LUPIN |
FENOFIBRATE | FENOFIBRATE | 130MG | CAPSULE;ORAL | Prescription | No | AB | 201748 | SUN PHARM INDS LTD |
FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 130MG | CAPSULE;ORAL | Prescription | No | AB | 202252 | APOTEX |
FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 130MG | CAPSULE;ORAL | Prescription | No | AB | 090859 | DR REDDYS LABS SA |