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Last Updated: January 25, 2021

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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
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020287
Generic Entry Date for 020287*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Regulatory Exclusivity Expiration:May 16, 2022
Regulatory Exclusivity Use:

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
Regulatory Exclusivity Expiration:May 16, 2022
Regulatory Exclusivity Use:

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
Regulatory Exclusivity Expiration:May 16, 2022
Regulatory Exclusivity Use:

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   Start Trial   Start Trial
Pfizer FRAGMIN dalteparin sodium INJECTABLE;SUBCUTANEOUS 020287-003 Mar 18, 1996   Start Trial   Start Trial
Pfizer FRAGMIN dalteparin sodium INJECTABLE;SUBCUTANEOUS 020287-004 Jan 30, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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