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Generated: December 19, 2018

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Details for New Drug Application (NDA): 040455

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NDA 040455 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma Farmaceutica, Metrics Pharm, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, and West-ward Pharms Int, and is included in seven NDAs. It is available from four 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. Seven suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.
Summary for 040455
Applicant:Teva Pharms Usa
Ingredient:norepinephrine bitartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 040455
Medical Subject Heading (MeSH) Categories for 040455
Suppliers and Packaging for NDA: 040455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOREPINEPHRINE BITARTRATE norepinephrine bitartrate INJECTABLE;INJECTION 040455 ANDA Teva Parenteral Medicines, Inc. 0703-1153 0703-1153-03 10 VIAL, SINGLE-USE in 1 CARTON (0703-1153-03) > 4 mL in 1 VIAL, SINGLE-USE (0703-1153-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Mar 3, 2003TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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