Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206127
Company: EUGIA PHARMA
Company: EUGIA PHARMA
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 |
---|---|---|---|---|---|---|---|
12/08/2015 | 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 |
---|---|---|---|---|---|
05/25/2023 | SUPPL-4 | Labeling-Package Insert |
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 | 206127 | EUGIA PHARMA |
EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213599 | HONG KONG |
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 | 213081 | SHUANGCHENG |
EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209864 | SLATE RUN PHARMA |
EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090854 | TEVA PHARMS USA |
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 | 208554 | BAXTER HLTHCARE CORP |
EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 206127 | EUGIA PHARMA |
EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213599 | HONG KONG |
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 |
EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213081 | SHUANGCHENG |
EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 209864 | SLATE RUN PHARMA |