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Details for New Drug Application (NDA): 020712

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NDA 020712 describes CARBATROL, which is a drug marketed by Shire and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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-four suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the carbamazepine profile page.

Summary for NDA: 020712

Tradename:
CARBATROL
Applicant:
Shire
Ingredient:
carbamazepine
Patents:1
Therapeutic Class:Anticonvulsants
Bipolar Agents
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 Shire US Manufacturing Inc. 54092-171 54092-171-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL 020712 NDA Shire US Manufacturing Inc. 54092-172 54092-172-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-172-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Sep 30, 1997TE:ABRLD:No
Patent:5,912,013Patent Expiration:Jun 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes
Patent:5,912,013Patent Expiration:Jun 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Sep 30, 1997TE:ABRLD:No
Patent:5,912,013Patent Expiration:Jun 15, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)

Expired Orange Book Patents for NDA: 020712

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 19975,326,570► subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-002Sep 30, 19975,326,570► subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-001Sep 30, 19975,912,013► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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