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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212441
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription AP No No
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML 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
07/24/2020 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
11/06/2020 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019953 B BRAUN
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 212441 FRESENIUS KABI USA
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 212441 FRESENIUS KABI USA
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200 UNITS/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 019953 B BRAUN
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 212441 FRESENIUS KABI USA
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 018609 BAXTER HLTHCARE
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription No AP 212441 FRESENIUS KABI USA
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE;INJECTION Prescription Yes AP 018916 HOSPIRA
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