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Last Updated: April 12, 2024

Details for New Drug Application (NDA): 014879

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NDA 014879 describes DOPRAM, which is a drug marketed by Hikma and is included in one NDA. It is available from two suppliers. Additional details are available on the DOPRAM profile page.

The generic ingredient in DOPRAM is doxapram hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the doxapram hydrochloride profile page.
Summary for 014879
Ingredient:doxapram hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 014879
Medical Subject Heading (MeSH) Categories for 014879
Suppliers and Packaging for NDA: 014879
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOPRAM doxapram hydrochloride INJECTABLE;INJECTION 014879 NDA Hikma Pharmaceuticals USA Inc. 0641-6018 0641-6018-01 20 mL in 1 VIAL (0641-6018-01)
DOPRAM doxapram hydrochloride INJECTABLE;INJECTION 014879 NDA Hikma Pharmaceuticals USA Inc. 0641-6018 0641-6018-06 6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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