Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091316
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 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

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