Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210093
Company: PURACAP PHARM LLC
Company: PURACAP PHARM LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | 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 |
|---|---|---|---|---|---|---|---|
| 06/15/2020 | 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 |
|---|---|---|---|---|---|
| 01/06/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
OMEGA-3-ACID ETHYL ESTERS
CAPSULE;ORAL; 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | Yes | AB | 021654 | WOODWARD |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 204940 | AMNEAL PHARMS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 090973 | APOTEX |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 207420 | ASCENT PHARMS INC |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 206455 | BIONPHARMA |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 211979 | CSPC-NBP PHARM |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 091028 | GLW |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 212504 | GLW |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 215458 | MANKIND PHARMA |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 210093 | PURACAP PHARM LLC |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 211355 | SOFGEN PHARMS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 203893 | STRIDES PHARMA |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE;ORAL | Prescription | No | AB | 210834 | SUN PHARM |