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Last Updated: October 20, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205758


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NDA 205758 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Nortec Dev Assoc, Par Pharm Inc, Teva Pharms Usa, Upsher Smith Labs, Hikma Pharms, Hospira, Hospira Inc, Icu Medical Inc, Intl Medication Sys, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Akorn, Ani Pharms, Lannett Co Inc, Nostrum Labs Inc, Padagis Us, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Winder Labs Llc, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Vintage Pharms Llc, Alkem Labs Ltd, Hikma, and Meridian Medcl Techn, and is included in fifty-eight NDAs. It is available from thirty-four 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-six suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 205758
Tradename:MORPHINE SULFATE
Applicant:Hikma Pharms
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205758
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 205758
Suppliers and Packaging for NDA: 205758
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 205758 ANDA Hikma Pharmaceuticals USA Inc. 0641-6125 0641-6125-25 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6125-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-6125-01)
MORPHINE SULFATE morphine sulfate INJECTABLE;INJECTION 205758 ANDA Hikma Pharmaceuticals USA Inc. 0641-6126 0641-6126-25 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6126-25) > 1 mL in 1 VIAL, SINGLE-DOSE (0641-6126-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MG/ML
Approval Date:May 21, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength8MG/ML
Approval Date:May 21, 2015TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:May 21, 2015TE:APRLD:No

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Harvard Business School

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