Details for New Drug Application (NDA): 019787

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NDA 019787 describes NORVASC, which is a drug marketed by Viatris and is included in one NDA. It is available from four 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. Forty-four suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.

Summary for 019787

Tradename:	NORVASC
Applicant:	Viatris
Ingredient:	amlodipine besylate
Patents:	0

Pharmacology for NDA: 019787

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

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	0069-1530-68	90 TABLET in 1 BOTTLE (0069-1530-68)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Jul 31, 1992	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 31, 1992	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 31, 1992	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019787

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	⤷ Get Started Free	⤷ Get Started Free
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992	⤷ Get Started Free	⤷ Get Started Free
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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