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Details for New Drug Application (NDA): 022154

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NDA 022154 describes TYZEKA, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the TYZEKA profile page.

The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the telbivudine profile page.

Summary for NDA: 022154

Tradename:
TYZEKA
Applicant:
Novartis
Ingredient:
telbivudine
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 022154

Suppliers and Packaging for NDA: 022154

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYZEKA
telbivudine
SOLUTION;ORAL 022154 NDA Novartis Pharmaceuticals Corporation 0078-0539 0078-0539-85 300 mL in 1 BOTTLE (0078-0539-85)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Apr 28, 2009TE:RLD:No
Regulatory Exclusivity Expiration:Jan 28, 2016
Regulatory Exclusivity Use:LONG TERM SAFETY AND EFFICACY DATA FROM STUDY CLDT600A2303 FOR SUBJECTS PREVIOUSLY ENROLLED IN THE ORIGINAL TWO YEAR GLOBE (NV-02B-007/CLDT600A2302) AND NV02B-015 STUDIES WHO CONTINUED TELBIVUDINE TREATMENT FOR UP TO 208 WEEKS
Patent:6,395,716Patent Expiration:Aug 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
Patent:6,444,652Patent Expiration:Aug 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS


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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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