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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
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Chinese Patent Office
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Generated: June 23, 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 ➤ Sign Up ➤ Sign Up
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-003 Aug 1, 1984 ➤ Sign Up ➤ Sign Up
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-004 Aug 1, 1984 ➤ Sign Up ➤ Sign Up
Schering NORMODYNE labetalol hydrochloride TABLET;ORAL 018687-001 Aug 31, 1987 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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