Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091316
Company: DR REDDYS LABS LTD

Products on ANDA 091316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	5MG/0.4ML	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	7.5MG/0.6ML	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	10MG/0.8ML	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091316

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.

Therapeutic Equivalents for ANDA 091316

FONDAPARINUX SODIUM

SOLUTION;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	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021345	MYLAN IRELAND LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	091316	DR REDDYS LABS LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206918	EUGIA PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206812	HENGRUI PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	2.5MG/0.5ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208615	SCINOPHARM TAIWAN

SOLUTION;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	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021345	MYLAN IRELAND LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	5MG/0.4ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	091316	DR REDDYS LABS LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	5MG/0.4ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206918	EUGIA PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	5MG/0.4ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206812	HENGRUI PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	5MG/0.4ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208615	SCINOPHARM TAIWAN

SOLUTION;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	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021345	MYLAN IRELAND LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	7.5MG/0.6ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	091316	DR REDDYS LABS LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	7.5MG/0.6ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206918	EUGIA PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	7.5MG/0.6ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206812	HENGRUI PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	7.5MG/0.6ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208615	SCINOPHARM TAIWAN

SOLUTION;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	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021345	MYLAN IRELAND LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	10MG/0.8ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	091316	DR REDDYS LABS LTD
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	10MG/0.8ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206918	EUGIA PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	10MG/0.8ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	206812	HENGRUI PHARMA
FONDAPARINUX SODIUM	FONDAPARINUX SODIUM	10MG/0.8ML	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208615	SCINOPHARM TAIWAN