Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206918
Company: AUROBINDO PHARMA 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
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 206918 AUROBINDO PHARMA 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 206812 JIANGSU HENGRUI MED
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 206918 AUROBINDO PHARMA 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 206812 JIANGSU HENGRUI MED
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 206918 AUROBINDO PHARMA 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 206812 JIANGSU HENGRUI MED
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 206918 AUROBINDO PHARMA 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 206812 JIANGSU HENGRUI MED
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE;SUBCUTANEOUS Prescription No AP 208615 SCINOPHARM TAIWAN

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English