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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
AstraZeneca
McKinsey
Cipla
Mallinckrodt
Cerilliant
Merck
Deloitte

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018687

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NDA 018687 describes NORMODYNE, which is a drug marketed by Schering and is included in two NDAs. Additional details are available on the NORMODYNE profile page.

The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 018687
Tradename:NORMODYNE
Applicant:Schering
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 31, 1987TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 1, 1984TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 1, 1984TE:RLD:Yes

Expired US Patents for NDA 018687

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-002 Aug 1, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-002 Aug 1, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-003 Aug 1, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-001 Aug 31, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Covington
Queensland Health
Federal Trade Commission
Cerilliant
Accenture
UBS
Chubb
Julphar

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