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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 Inc and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the dalteparin sodium profile page.

Summary for NDA: 020287

Tradename:
FRAGMIN
Applicant:
Pfizer Inc
Ingredient:
dalteparin sodium
Patents:0
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
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;INJECTION 020287 NDA Pfizer Laboratories Div Pfizer Inc 0069-0196 0069-0196-02 10 SYRINGE in 1 CARTON (0069-0196-02) > .2 mL in 1 SYRINGE (0069-0196-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength2,500IU/0.2ML (12,500IU/ML)
Approval Date:Dec 22, 1994TE:RLD:No

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:No

Expired Orange Book Patents for NDA: 020287

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc
FRAGMIN
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-001Dec 22, 19944,303,651► subscribe
Pfizer Inc
FRAGMIN
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-004Jan 30, 19984,303,651► subscribe
Pfizer Inc
FRAGMIN
dalteparin sodium
INJECTABLE;SUBCUTANEOUS020287-003Mar 18, 19964,303,651► subscribe
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