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Details for New Drug Application (NDA): 088432

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NDA 088432 describes MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Eurohlth Intl Sarl, Hospira, Intl Medication, Watson Labs, and Mallinckrodt, and is included in six NDAs. It is available from one supplier. Additional details are available on the MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE is meperidine hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.

Summary for NDA: 088432

Tradename:
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:
Hospira
Ingredient:
meperidine hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 088432

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 088432

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
meperidine hydrochloride
INJECTABLE;INJECTION 088432 ANDA Hospira, Inc. 0409-6030 0409-6030-04 10 CARTON in 1 PACKAGE (0409-6030-04) > 1 VIAL, PATENT DELIVERY SYSTEM in 1 CARTON > 30 mL in 1 VIAL, PATENT DELIVERY SYSTEM

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Aug 16, 1984TE:APRLD:Yes


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