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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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Queensland Health

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075295

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NDA 075295 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, Hi-tech Pharmacal, Lannett Holdings Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vintage Pharms Llc, 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, and Sun Pharm Industries, and is included in fifty-three NDAs. It is available from forty-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. Fifty-two suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 075295
Applicant:Vintage Pharms Llc
Ingredient:morphine sulfate
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075295
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 075295
Suppliers and Packaging for NDA: 075295
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 075295 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-845 N 49999-845-30
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 075295 ANDA Physicians Total Care, Inc. 54868-4033 E 54868-4033-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Oct 28, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Oct 28, 1998TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Oct 28, 1998TE:ABRLD:No

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