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Last Updated: August 15, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080445

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NDA 080445 describes MEPERIDINE HYDROCHLORIDE, which is a drug marketed by Abbott, Baxter Hlthcare, Igi Labs Inc, Intl Medication, Parke Davis, Watson Labs, West-ward Pharms Int, Hikma, Anda Repository, Barr, Duramed Pharms Barr, Epic Pharma, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Vintage Pharms, Wyeth Ayerst, Hospira, and Icu Medical Inc, and is included in forty-two NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 080445
Tradename:MEPERIDINE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:meperidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 080445
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 080445
Suppliers and Packaging for NDA: 080445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEPERIDINE HYDROCHLORIDE meperidine hydrochloride INJECTABLE;INJECTION 080445 ANDA West-Ward Pharmaceuticals Corp. 0641-6052 0641-6052-25 25 VIAL in 1 CARTON (0641-6052-25) > 1 mL in 1 VIAL (0641-6052-01)
MEPERIDINE HYDROCHLORIDE meperidine hydrochloride INJECTABLE;INJECTION 080445 ANDA West-Ward Pharmaceuticals Corp. 0641-6053 0641-6053-25 25 VIAL in 1 CARTON (0641-6053-25) > 1 mL in 1 VIAL (0641-6053-01)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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