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Generated: April 23, 2019

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Details for New Drug Application (NDA): 019787

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

The generic ingredient in NORVASC is amlodipine besylate. There are fifty drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.
Summary for 019787
Tradename:NORVASC
Applicant:Pfizer
Ingredient:amlodipine besylate
Patents:0
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
NORVASC amlodipine besylate TABLET;ORAL 019787 NDA Pfizer Laboratories Div Pfizer Inc 0069-1520 0069-1520-68 90 TABLET in 1 BOTTLE (0069-1520-68)
NORVASC 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 31, 1992TE:ABRLD:Yes

Profile for product number 003

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

Expired US Patents for NDA 019787

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-002 Jul 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-003 Jul 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer NORVASC amlodipine besylate TABLET;ORAL 019787-001 Jul 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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