Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204693
Company: SAGENT PHARMS INC
Company: SAGENT PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/2018 | ORIG-1 | Approval |
Label is not available on this site. |
EPTIFIBATIDE
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205557 | ACCORD HLTHCARE |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204589 | AKORN |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205581 | AMNEAL PHARMS |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206127 | AUROBINDO PHARMA LTD |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208554 | BAXTER HLTHCARE CORP |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209864 | HAINAN POLY PHARM |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203258 | MYLAN LABS LTD |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204693 | SAGENT PHARMS INC |
| EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090854 | TEVA PHARMS USA |
| INTEGRILIN | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020718 | SCHERING |
INJECTABLE;INJECTION; 75MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 205557 | ACCORD HLTHCARE |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 204589 | AKORN |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 205581 | AMNEAL PHARMS |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206127 | AUROBINDO PHARMA LTD |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 208554 | BAXTER HLTHCARE CORP |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 209864 | HAINAN POLY PHARM |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 203258 | MYLAN LABS LTD |
| EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 204693 | SAGENT PHARMS INC |
| INTEGRILIN | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020718 | SCHERING |
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