Last Updated: August 2, 2026

Details for New Drug Application (NDA): 074769

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NDA 074769 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Anda Repository, Impax Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms, Chartwell Molecular, Padagis Us, Pharm Assoc, Rhodes Pharms, Sankalp Lifecare, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Nesher Pharms, Novel Labs Inc, Rising, Sun Pharm Inds Ltd, Sun Pharm Industries, Alkem Labs Ltd, Ingenus Pharms Nj, and Meridian Medcl Techn, and is included in sixty-two NDAs. It is available from twenty-four suppliers. There are three patents protecting this drug. Additional details are available on the MORPHINE SULFATE profile page.

The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 074769

Tradename:	MORPHINE SULFATE
Applicant:	Rhodes Pharms
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 074769

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 074769

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 074769

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	074769	ANDA	Major Pharmaceuticals	0904-6560	0904-6560-61	100 BLISTER PACK in 1 CARTON (0904-6560-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
MORPHINE SULFATE	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	074769	ANDA	Rhodes Pharmaceuticals LLC	42858-804	42858-804-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-804-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Jul 2, 1998	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Jul 2, 1998	TE:	AB	RLD:	No

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