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Details for New Drug Application (NDA): 080455

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NDA 080455 describes MEPERIDINE HYDROCHLORIDE, which is a drug marketed by Roxane, Duramed Pharms Barr, Epic Pharma, Intl Medication, Barr, Watson Labs, Eurohlth Intl Sarl, Sun Pharm Inds Inc, Sun Pharm Inds, Mallinckrodt, Wyeth Ayerst, Parke Davis, Baxter Hlthcare, Igi Labs Inc, Abbott, Vintage Pharms, Mikart, and Hospira, and is included in forty-two NDAs. It is available from nine suppliers. Additional details are available on the MEPERIDINE HYDROCHLORIDE profile page.

The generic ingredient in MEPERIDINE HYDROCHLORIDE 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: 080455

Tradename:
MEPERIDINE HYDROCHLORIDE
Applicant:
Eurohlth Intl Sarl
Ingredient:
meperidine hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 080455

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 080455

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEPERIDINE HYDROCHLORIDE
meperidine hydrochloride
INJECTABLE;INJECTION 080455 ANDA Physicians Total Care, Inc. 54868-3559 54868-3559-1 25 VIAL in 1 PACKAGE (54868-3559-1) > 1 mL in 1 VIAL

Summary for product number 007

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Summary for product number 008

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Summary for product number 009

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No


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