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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 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

Tradename:
NORVASC
Applicant:
Pfizer
Ingredient:
amlodipine besylate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019787

Ingredient-typeDihydropyridines
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

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

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