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. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
The generic ingredient in EQUETRO is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six 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 |
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 | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 19, 2024 | Product 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: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 10, 2004 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 19, 2024 | Product 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: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Dec 10, 2004 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 19, 2024 | Product 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 | 021710-001 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-002 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-002 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-003 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-003 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-003 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-002 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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