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Details for New Drug Application (NDA): 205353

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NDA 205353 describes FARYDAK, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the FARYDAK profile page.

The generic ingredient in FARYDAK is panobinostat lactate. One supplier is listed for this compound. Additional details are available on the panobinostat lactate profile page.

Summary for NDA: 205353

Tradename:
FARYDAK
Applicant:
Novartis Pharms Corp
Ingredient:
panobinostat lactate
Patents:5

Pharmacology for NDA: 205353

Suppliers and Packaging for NDA: 205353

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FARYDAK
panobinostat lactate
CAPSULE;ORAL 205353 NDA Novartis Pharmaceuticals Corporation 0078-0650 0078-0650-06 6 CAPSULE in 1 BLISTER PACK (0078-0650-06)
FARYDAK
panobinostat lactate
CAPSULE;ORAL 205353 NDA Novartis Pharmaceuticals Corporation 0078-0651 0078-0651-06 6 CAPSULE in 1 BLISTER PACK (0078-0651-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Feb 23, 2015TE:RLD:No
Patent:6,552,065Patent Expiration:Aug 31, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,989,494Patent Expiration:Jan 17, 2028Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Feb 23, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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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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