U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208615
Company: SCINOPHARM TAIWAN

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
11/14/2018 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2023 SUPPL-3 Labeling-Medication Guide, 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 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
Back to Top