Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203851
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM HEPARIN SODIUM 10,000 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/2017/203851Orig1s000ltr.pdf

HEPARIN SODIUM

INJECTABLE;INJECTION; 1,000 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 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211005 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091682 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202957 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090810 SAGENT PHARMS
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202732 SHENZHEN TECHDOW

INJECTABLE;INJECTION; 5,000 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 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091659 CASI PHARMS INC
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017651 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 206552 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 205323 GLAND PHARMA LTD
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091682 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202733 SHENZHEN TECHDOW
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202957 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA

INJECTABLE;INJECTION; 10,000 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 10,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 201002 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203198 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA

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