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Last Updated: September 26, 2022

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 three 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. Thirty-nine 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 AUTHORIZED GENERIC ATLANTIC BIOLOGICALS CORP. 17856-0407 17856-0407-1 100 POUCH in 1 BOX, UNIT-DOSE (17856-0407-1) > 1 CAPSULE, EXTENDED RELEASE in 1 POUCH
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Sep 30, 1997TE:ABRLD: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 020712-003 Sep 30, 1997 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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