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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 211452

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NDA 211452 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 211452

Tradename:	MORPHINE SULFATE
Applicant:	Hikma
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 211452

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 211452

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 211452

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	211452	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6191	0641-6191-10	10 SYRINGE in 1 PACKAGE (0641-6191-10) / 1 mL in 1 SYRINGE
MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	211452	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6192	0641-6192-10	10 SYRINGE in 1 PACKAGE (0641-6192-10) / 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Jan 12, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4MG/ML
Approval Date:	Jan 12, 2023	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	8MG/ML
Approval Date:	Jan 12, 2023	TE:	AP	RLD:	No

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