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Details for New Drug Application (NDA): 021710

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NDA 021710 describes EQUETRO, which is a drug marketed by Validus Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. 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. There are three tentative approvals for this compound. Additional details are available on the carbamazepine profile page.

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Dec 10, 2004TE:RLD:No
Patent:5,912,013Patent Expiration:Jun 15, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,977,253Patent Expiration:May 19, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Dec 10, 2004TE:RLD:No
Patent:5,912,013Patent Expiration:Jun 15, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021710

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms Inc
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-001Dec 10, 20045,326,570► subscribe
Validus Pharms Inc
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-002Dec 10, 20045,326,570► subscribe
Validus Pharms Inc
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-003Dec 10, 20045,912,013► subscribe
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