Details for New Drug Application (NDA): 018830

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NDA 018830 describes TAMBOCOR, which is a drug marketed by Alvogen and is included in one NDA. Additional details are available on the TAMBOCOR profile page.

The generic ingredient in TAMBOCOR is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

Summary for 018830

Tradename:	TAMBOCOR
Applicant:	Alvogen
Ingredient:	flecainide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 018830

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 1985	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 1985	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 3, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 018830

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	3,900,481	⤷ Subscribe
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	4,005,209	⤷ Subscribe
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	4,642,384	⤷ Subscribe
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988	3,800,481	⤷ Subscribe
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	3,900,481	⤷ Subscribe
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	4,005,209	⤷ Subscribe
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	4,642,384	⤷ Subscribe
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