Details for New Drug Application (NDA): 020712
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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 |
Formulation / Manufacturing: | see details |
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 | 020712-002 | 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 | 020712-002 | 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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