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): 019787

« Back to Dashboard
NDA 019787 describes NORVASC, which is a drug marketed by Pfizer and is included in one NDA. It is available from twelve suppliers. Additional details are available on the NORVASC profile page.

The generic ingredient in NORVASC is amlodipine besylate. There are forty-nine drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. There are sixteen tentative approvals for this compound. Additional details are available on the amlodipine besylate profile page.

Summary for NDA: 019787

amlodipine besylate
Formulation / Manufacturing:see details

Pharmacology for NDA: 019787

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 019787

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amlodipine besylate
TABLET;ORAL 019787 NDA Pfizer Laboratories Div Pfizer Inc 0069-1520 0069-1520-68 90 TABLET in 1 BOTTLE (0069-1520-68)
amlodipine besylate
TABLET;ORAL 019787 NDA Pfizer Laboratories Div Pfizer Inc 0069-1530 0069-1530-41 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0069-1530-41) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 1992TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 31, 1992TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 31, 1992TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019787

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
amlodipine besylate
TABLET;ORAL019787-001Jul 31, 19924,572,909*PED► subscribe
amlodipine besylate
TABLET;ORAL019787-002Jul 31, 19924,879,303*PED► subscribe
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,879,303*PED► 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.