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Last Updated: March 16, 2025

Details for New Drug Application (NDA): 021710

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NDA 021710 describes EQUETRO, which is a drug marketed by Validus Pharms and is included in one NDA. 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-four 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

Medical Subject Heading (MeSH) Categories for 021710

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

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

Show entries

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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

Showing 1 to 6 of 6 entries

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