Details for New Drug Application (NDA): 020712

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NDA 020712 describes CARBATROL, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the CARBATROL profile page.

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

Summary for 020712

Tradename:	CARBATROL
Applicant:	Takeda Pharms Usa
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 020712

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 020712

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

Suppliers and Packaging for NDA: 020712

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712	NDA	Takeda Pharmaceuticals America, Inc.	54092-171	54092-171-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)
CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712	NDA	Takeda Pharmaceuticals America, Inc.	54092-172	54092-172-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-172-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Sep 30, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020712

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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