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Last Updated: July 7, 2020

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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 and is included in one NDA. It is available from one supplier. There is one patent 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. Thirty-five 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:1
Formulation / Manufacturing:see details
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)
Paragraph IV (Patent) Challenges for 021710
Tradename Dosage Ingredient NDA Submissiondate
EQUETRO CAPSULE, EXTENDED RELEASE;ORAL carbamazepine 021710 2014-05-23
EQUETRO CAPSULE, EXTENDED RELEASE;ORAL carbamazepine 021710 2007-08-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Dec 10, 2004TE:RLD:Yes
Patent:  Start TrialPatent 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.

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Dec 10, 2004TE:RLD:Yes
Patent:  Start TrialPatent 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.

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Dec 10, 2004TE:RLD:Yes
Patent:  Start TrialPatent 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.

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 021710-003 Dec 10, 2004   Start Trial   Start Trial
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004   Start Trial   Start Trial
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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