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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074278

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NDA 074278 describes LEVORPHANOL TARTRATE, which is a drug marketed by Acertis Pharms, Hikma, Novitium Pharma, Specgx Llc, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the LEVORPHANOL TARTRATE profile page.

The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.

Summary for 074278

Tradename:	LEVORPHANOL TARTRATE
Applicant:	Hikma
Ingredient:	levorphanol tartrate
Patents:	0

Pharmacology for NDA: 074278

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 074278

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 074278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	074278	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0438	0054-0438-25	100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Mar 31, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jun 18, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Jun 18, 2018	TE:		RLD:	No

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