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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 020631

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NDA 020631 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-six 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-eight suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 020631

Tradename:	MORPHINE SULFATE
Applicant:	Specgx Llc
Ingredient:	morphine sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 020631

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Jul 3, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Jul 3, 1996	TE:		RLD:	No

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