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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021321


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NDA 021321 describes EXTRANEAL, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the EXTRANEAL profile page.

The generic ingredient in EXTRANEAL is icodextrin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the icodextrin profile page.
Summary for 021321
Tradename:EXTRANEAL
Applicant:Baxter Hlthcare
Ingredient:icodextrin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTRANEAL icodextrin SOLUTION;INTRAPERITONEAL 021321 NDA Baxter Healthcare Corporation 0941-0679 0941-0679-05 2500 mL in 1 BAG (0941-0679-05)
EXTRANEAL icodextrin SOLUTION;INTRAPERITONEAL 021321 NDA Baxter Healthcare Corporation 0941-0679 0941-0679-06 2000 mL in 1 BAG (0941-0679-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength7.5GM/100ML
Approval Date:Dec 20, 2002TE:RLD:Yes

Expired US Patents for NDA 021321

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare EXTRANEAL icodextrin SOLUTION;INTRAPERITONEAL 021321-001 Dec 20, 2002 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare EXTRANEAL icodextrin SOLUTION;INTRAPERITONEAL 021321-001 Dec 20, 2002 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare EXTRANEAL icodextrin SOLUTION;INTRAPERITONEAL 021321-001 Dec 20, 2002 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare EXTRANEAL icodextrin SOLUTION;INTRAPERITONEAL 021321-001 Dec 20, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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