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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 020287


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NDA 020287 describes FRAGMIN, which is a drug marketed by Pfizer 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 020287
Tradename:FRAGMIN
Applicant:Pfizer
Ingredient:dalteparin sodium
Patents:0
Pharmacology for NDA: 020287
Medical Subject Heading (MeSH) Categories for 020287
Suppliers and Packaging for NDA: 020287
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FRAGMIN 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)
FRAGMIN 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)

Profile for product number 001

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

Profile for product number 002

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

Profile 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 US Patents for NDA 020287

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer FRAGMIN dalteparin sodium INJECTABLE;SUBCUTANEOUS 020287-001 Dec 22, 1994 ⤷  Sign Up ⤷  Sign Up
Pfizer FRAGMIN dalteparin sodium INJECTABLE;SUBCUTANEOUS 020287-004 Jan 30, 1998 ⤷  Sign Up ⤷  Sign Up
Pfizer FRAGMIN dalteparin sodium INJECTABLE;SUBCUTANEOUS 020287-003 Mar 18, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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