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Generated: April 28, 2017

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Details for New Drug Application (NDA): 018132

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NDA 018132 describes DOPAMINE HYDROCHLORIDE, which is a drug marketed by Teva Parenteral, Hospira, Smith And Nephew, Abraxis Pharm, Intl Medication, Luitpold, Warner Chilcott, Lyphomed, Abbott, Igi Labs Inc, Baxter Hlthcare, and B Braun, and is included in thirty-five NDAs. It is available from six suppliers. Additional details are available on the DOPAMINE HYDROCHLORIDE profile page.

The generic ingredient in DOPAMINE HYDROCHLORIDE is dopamine hydrochloride. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dopamine hydrochloride profile page.

Summary for NDA: 018132

Formulation / Manufacturing:see details

Pharmacology for NDA: 018132


Suppliers and Packaging for NDA: 018132

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dopamine hydrochloride
INJECTABLE;INJECTION 018132 NDA Hospira, Inc. 0409-4142 0409-4142-02 12 BOTTLE, GLASS in 1 CASE (0409-4142-02) > 250 mL in 1 BOTTLE, GLASS
dopamine hydrochloride
INJECTABLE;INJECTION 018132 NDA Hospira, Inc. 0409-4265 0409-4265-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4265-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/100ML
Approval Date:Feb 4, 1982TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength160MG/100ML
Approval Date:Feb 4, 1982TE:APRLD:Yes

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