You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for New Drug Application (NDA): 202861


✉ Email this page to a colleague

« Back to Dashboard


NDA 202861 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Strides Pharma, 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, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, 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-eight 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. Thirty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 202861
Tradename:MORPHINE SULFATE
Applicant:Intl Medication Sys
Ingredient:morphine sulfate
Patents:0
Pharmacology for NDA: 202861
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 202861
Suppliers and Packaging for NDA: 202861
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 202861 ANDA International Medication Systems, Limited 76329-1912 76329-1912-1 1 VIAL in 1 CARTON (76329-1912-1) / 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 29, 2021TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.