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Details for New Drug Application (NDA): 022103

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NDA 022103 describes SANCTURA XR, which is a drug marketed by Allergan and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SANCTURA XR profile page.

The generic ingredient in SANCTURA XR is trospium chloride. There are sixteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for NDA: 022103

Tradename:
SANCTURA XR
Applicant:
Allergan
Ingredient:
trospium chloride
Patents:5
Therapeutic Class:Genitourinary Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 3, 2007TE:RLD:No
Patent:7,410,978Patent Expiration:Feb 1, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,759,359Patent Expiration:Nov 4, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION
Patent:7,763,635Patent Expiration:Nov 4, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION


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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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