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Generated: November 13, 2018

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Details for New Drug Application (NDA): 014879

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NDA 014879 describes DOPRAM, which is a drug marketed by West-ward Pharms Int and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the doxapram hydrochloride profile page.
Summary for 014879
Applicant:West-ward Pharms Int
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 West-ward Pharmaceutical Corp. 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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