Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074862

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NDA 074862 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher Smith Labs, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms Inc, Hi Tech, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, West-ward Pharms Int, 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, and Hikma, and is included in fifty-four NDAs. It is available from thirty-nine 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. Forty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 074862
Tradename:MORPHINE SULFATE
Applicant:Rhodes Pharms
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074862
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 074862
Suppliers and Packaging for NDA: 074862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 074862 ANDA Major Pharmaceuticals 0904-6557 0904-6557-61 100 BLISTER PACK in 1 CARTON (0904-6557-61) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 074862 ANDA Major Pharmaceuticals 0904-6558 0904-6558-61 100 BLISTER PACK in 1 CARTON (0904-6558-61) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Jul 7, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jul 7, 1998TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Jul 7, 1998TE:ABRLD:No

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