Details for New Drug Application (NDA): 020712
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NDA 020712 describes CARBATROL, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the CARBATROL profile page.
The generic ingredient in CARBATROL 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 CARBATROL 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 020712
| Tradename: | CARBATROL |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | carbamazepine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020712
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-171 | 54092-171-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12) |
| CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-172 | 54092-172-12 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-172-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 30, 1997 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 30, 1997 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 30, 1997 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020712
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-002 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-003 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-002 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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