Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206918
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | AP | No | No |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
12/26/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206918Orig1s000ltr.pdf |
FONDAPARINUX SODIUM
INJECTABLE;SUBCUTANEOUS; 2.5MG/0.5ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIXTRA | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 021345 | MYLAN IRELAND LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 091316 | DR REDDYS LABS LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |
INJECTABLE;SUBCUTANEOUS; 5MG/0.4ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIXTRA | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 021345 | MYLAN IRELAND LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 091316 | DR REDDYS LABS LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |
INJECTABLE;SUBCUTANEOUS; 7.5MG/0.6ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIXTRA | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 021345 | MYLAN IRELAND LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 091316 | DR REDDYS LABS LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |
INJECTABLE;SUBCUTANEOUS; 10MG/0.8ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIXTRA | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 021345 | MYLAN IRELAND LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 091316 | DR REDDYS LABS LTD |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |