Details for New Drug Application (NDA): 021710

NDA 021710 describes EQUETRO, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the EQUETRO profile page.

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

Summary for 021710

Tradename:	EQUETRO
Applicant:	Validus Pharms
Ingredient:	carbamazepine
Patents:	0

Pharmacology for NDA: 021710

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 021710

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Suppliers and Packaging for NDA: 021710

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710	NDA	Validus Pharmaceuticals LLC	30698-419	30698-419-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-419-12)
EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710	NDA	Validus Pharmaceuticals LLC	30698-421	30698-421-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Dec 10, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Dec 10, 2004	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Dec 10, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021710

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	5,912,013
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	6,977,253
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	5,326,570
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	5,326,570
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	6,977,253
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	5,326,570
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	6,977,253

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