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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Johnson and Johnson
Express Scripts
Queensland Health

Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020287

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NDA 020287 describes FRAGMIN, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. Additional details are available on the FRAGMIN profile page.

The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.

Summary for NDA: 020287

Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 020287

Suppliers and Packaging for NDA: 020287

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dalteparin sodium
INJECTABLE;INJECTION 020287 NDA Pfizer Laboratories Div Pfizer Inc 0069-0195 0069-0195-02 10 SYRINGE in 1 CARTON (0069-0195-02) > .2 mL in 1 SYRINGE (0069-0195-01)
dalteparin sodium
INJECTABLE;SUBCUTANEOUS 020287 NDA Pfizer Laboratories Div Pfizer Inc 0069-0195 0069-0195-02 10 SYRINGE in 1 CARTON (0069-0195-02) > .2 mL in 1 SYRINGE (0069-0195-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength2,500IU/0.2ML (12,500IU/ML)
Approval Date:Dec 22, 1994TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength10,000IU/0.4ML (25,000IU/ML)
Approval Date:May 1, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength5,000IU/0.2ML (25,000IU/ML)
Approval Date:Mar 18, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020287

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-001Dec 22, 1994► Subscribe► Subscribe
Pfizer Inc
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-004Jan 30, 1998► Subscribe► Subscribe
Pfizer Inc
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-003Mar 18, 1996► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Boehringer Ingelheim
Harvard Business School
Daiichi Sankyo

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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