Details for New Drug Application (NDA): 020234
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NDA 020234 describes TEGRETOL-XR, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. Additional details are available on the TEGRETOL-XR profile page.
The generic ingredient in TEGRETOL-XR 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 TEGRETOL-XR 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 020234
| Tradename: | TEGRETOL-XR |
| Applicant: | Novartis |
| Ingredient: | carbamazepine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020234
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234 | NDA | Novartis Pharmaceuticals Corporation | 0078-0510 | 0078-0510-05 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05) |
| TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234 | NDA | Novartis Pharmaceuticals Corporation | 0078-0511 | 0078-0511-05 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 25, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Mar 25, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Mar 25, 1996 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020234
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-002 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-001 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-003 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-002 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-003 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-001 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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