Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203852
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION 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
11/30/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203852Orig1s000ltr.pdf

HEPARIN SODIUM

INJECTABLE;INJECTION; 20,000 UNITS/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203852 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090809 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203198 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA

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