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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211005
Company: EMERGE BIOSCIENCE

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/14/2018 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
02/20/2026 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
10/25/2021 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/29/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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 No AP 214804 BE PHARMS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211005 EMERGE BIOSCIENCE
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 EMERGE BIOSCIENCE
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 No AP 205323 GLAND
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 PHARMOBEDIENT
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091682 PLANO PHARMS
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 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
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