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Last Updated: April 25, 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020287

Medical Subject Heading (MeSH) Categories for 020287

Anticoagulants
Fibrinolytic Agents

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:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	2,500IU/0.2ML (12,500IU/ML)
Approval Date:	Dec 22, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	10,000IU/0.4ML (25,000IU/ML)
Approval Date:	May 1, 2007	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	5,000IU/0.2ML (25,000IU/ML)
Approval Date:	Mar 18, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020287

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

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