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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212451

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NDA 212451 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 212451

Tradename:	MORPHINE SULFATE
Applicant:	Alkem Labs Ltd
Ingredient:	morphine sulfate
Patents:	0

Pharmacology for NDA: 212451

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 212451

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 212451

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MORPHINE SULFATE	morphine sulfate	TABLET;ORAL	212451	ANDA	Bryant Ranch Prepack	63629-8459	63629-8459-1	100 TABLET in 1 BOTTLE (63629-8459-1)
MORPHINE SULFATE	morphine sulfate	TABLET;ORAL	212451	ANDA	Bryant Ranch Prepack	63629-8460	63629-8460-1	100 TABLET in 1 BOTTLE (63629-8460-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Dec 3, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Dec 3, 2020	TE:	AB	RLD:	No

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