Details for New Drug Application (NDA): 020234

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NDA 020234 describes TEGRETOL-XR, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. Additional details are available on the TEGRETOL-XR profile page.

The generic ingredient in TEGRETOL-XR is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 020234

Tradename:	TEGRETOL-XR
Applicant:	Novartis
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 020234

Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 020234

Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Cytochrome P-450 CYP3A Inducers

Suppliers and Packaging for NDA: 020234

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234	NDA	Novartis Pharmaceuticals Corporation	0078-0510	0078-0510-05	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05)
TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234	NDA	Novartis Pharmaceuticals Corporation	0078-0511	0078-0511-05	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Mar 25, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Mar 25, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	400MG
Approval Date:	Mar 25, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020234

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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