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Last Updated: June 15, 2021

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Details for New Drug Application (NDA): 075055


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NDA 075055 describes CAPTOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Cosette, Ivax Sub Teva Pharms, Mylan, Vintage Pharms Llc, and Watson Labs, and is included in five NDAs. It is available from one supplier. Additional details are available on the CAPTOPRIL AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in CAPTOPRIL AND HYDROCHLOROTHIAZIDE is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.
Summary for 075055

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;15MG
Approval Date:Jun 18, 1998TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;25MG
Approval Date:Jun 18, 1998TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG;25MG
Approval Date:Jun 18, 1998TE:RLD:No

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