.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018687

« Back to Dashboard
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 thirteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for NDA: 018687

Tradename:
NORMODYNE
Applicant:
Schering
Ingredient:
labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Expired Orange Book Patents for NDA: 018687

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
NORMODYNE
labetalol hydrochloride
TABLET;ORAL018687-001Aug 31, 19874,012,444► subscribe
Schering
NORMODYNE
labetalol hydrochloride
TABLET;ORAL018687-003Aug 1, 19844,012,444► subscribe
Schering
NORMODYNE
labetalol hydrochloride
TABLET;ORAL018687-004Aug 1, 19844,012,444► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc