Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091316
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 07/11/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091316s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/18/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/19/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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 | 216493 | HANGZHOU ZHONGMEI |
| 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 | 216493 | HANGZHOU ZHONGMEI |
| 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 | 216493 | HANGZHOU ZHONGMEI |
| 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 | 216493 | HANGZHOU ZHONGMEI |
| 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 |