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Details for New Drug Application (NDA): 018814

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NDA 018814 describes HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER is heparin sodium. There are seventy-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Summary for NDA: 018814

Tradename:
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:
Baxter Hlthcare
Ingredient:
heparin sodium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 018814

Ingredient-typeHeparin

Suppliers and Packaging for NDA: 018814

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
heparin sodium
INJECTABLE;INJECTION 018814 NDA Baxter Healthcare Corporation 0338-0549 0338-0549-03 500 mL in 1 BAG (0338-0549-03)
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
heparin sodium
INJECTABLE;INJECTION 018814 NDA Baxter Healthcare Corporation 0338-0549 0338-0549-03 500 mL in 1 BAG (0338-0549-03)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength4,000 UNITS/100ML
Approval Date:Oct 31, 1983TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2,000 UNITS/100ML
Approval Date:Jul 9, 1985TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/100ML
Approval Date:Jul 9, 1985TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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