Details for New Drug Application (NDA): 019787

✉ Email this page to a colleague

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-seven 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	0069-1530-41	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:	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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & 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 verification 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.