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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203158

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NDA 203158 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 203158

Tradename:	MORPHINE SULFATE
Applicant:	Anda Repository
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 203158

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 203158

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 203158

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	203158	ANDA	Nortec Development Associates, Inc.	42689-005	42689-005-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01)
MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	203158	ANDA	Nortec Development Associates, Inc.	42689-006	42689-006-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-006-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Aug 4, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Aug 4, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Aug 4, 2021	TE:		RLD:	No

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