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Generated: April 23, 2017

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Details for New Drug Application (NDA): 019805

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NDA 019805 describes HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Hospira and B Braun and is included in four NDAs. It is available from two suppliers. Additional details are available on the HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

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

Summary for NDA: 019805

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 019805

Ingredient-typeHeparin

Suppliers and Packaging for NDA: 019805

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
heparin sodium
INJECTABLE;INJECTION 019805 NDA Hospira, Inc. 0409-7760 0409-7760-03 24 POUCH in 1 CASE (0409-7760-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-7760-13)
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
heparin sodium
INJECTABLE;INJECTION 019805 NDA Hospira, Inc. 0409-7761 0409-7761-03 24 POUCH in 1 CASE (0409-7761-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-7761-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4,000 UNITS/100ML
Approval Date:Jan 25, 1989TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/100ML
Approval Date:Jan 25, 1989TE:APRLD: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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