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Last Updated: November 16, 2024

Details for New Drug Application (NDA): 080448

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NDA 080448 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, Barr, Duramed Pharms Barr, Epic Pharma Llc, Genus, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Wyeth Ayerst, Hospira, and Icu Medical Inc, and is included in forty-two NDAs. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.

Summary for 080448

Tradename:	MEPERIDINE HYDROCHLORIDE
Applicant:	Sun Pharm Industries
Ingredient:	meperidine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 080448

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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