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FDA Drug information

Dobutamine

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Adverse Reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch. "1-800-FDA-1088"

Effective Time

20230505

Version

1

Spl Product Data Elements

Dobutamine Dobutamine DOBUTAMINE HYDROCHLORIDE DOBUTAMINE SODIUM METABISULFITE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Application Number

ANDA074277

Brand Name

Dobutamine

Generic Name

Dobutamine

Product Ndc

62778-350

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL NDC 0143- 9141 -01 Rx only DOBUTamine Injection, USP 250 mg per 20 mL (12.5 mg/mL) For Intravenous Use ONLY Must be diluted prior to use Use within 24 hours after dilution 20 mL Single-Dose Vial NDC 0143- 9141 -10 Rx only DOBUTamine Injection, USP 250 mg per 20 mL (12.5 mg/mL) For Intravenous Use ONLY Must be diluted prior to use Use within 24 hours after dilution 10 x 20 mL Single-Dose Vials vial label carton label

Drug section

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