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Details for New Drug Application (NDA): 020719

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NDA 020719 describes PRELAY, which is a drug marketed by Sankyo and is included in one NDA. There are two patents protecting this drug. Additional details are available on the PRELAY profile page.

The generic ingredient in PRELAY is troglitazone. Additional details are available on the troglitazone profile page.

Summary for NDA: 020719

Tradename:
PRELAY
Applicant:
Sankyo
Ingredient:
troglitazone
Patents:2
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Jan 29, 1997TE:RLD:No
Patent:6,011,049Patent Expiration:Nov 13, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE TREATMENT OF TYPE II DIABETES
Patent:5,859,037Patent Expiration:Nov 13, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II DIABETES

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Jan 29, 1997TE:RLD:No
Patent:6,011,049Patent Expiration:Nov 13, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE TREATMENT OF TYPE II DIABETES

Expired Orange Book Patents for NDA: 020719

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 19975,602,133► subscribe
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-002Jan 29, 19975,457,109► subscribe
Sankyo
PRELAY
troglitazone
TABLET;ORAL020719-003Aug 4, 19975,457,109► 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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