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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
Daiichi Sankyo

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040859

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NDA 040859 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Metrics Pharm, Teva Pharms Usa, and West-ward Pharms Int, and is included in four NDAs. It is available from three suppliers. Additional details are available on the NOREPINEPHRINE BITARTRATE profile page.

The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 040859
Applicant:Baxter Hlthcare Corp
Ingredient:norepinephrine bitartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 040859
Medical Subject Heading (MeSH) Categories for 040859
Suppliers and Packaging for NDA: 040859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOREPINEPHRINE BITARTRATE norepinephrine bitartrate INJECTABLE;INJECTION 040859 ANDA Baxter Healthcare Corporation 36000-162 N 36000-162-10
NOREPINEPHRINE BITARTRATE norepinephrine bitartrate INJECTABLE;INJECTION 040859 ANDA Cardinal Health 55154-4450 N 55154-4450-8

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Mar 27, 2012TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Johnson and Johnson
Argus Health
Federal Trade Commission
Cantor Fitzgerald

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