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Details for New Drug Application (NDA): 018709

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NDA 018709 describes CAPOZIDE 50/25, which is a drug marketed by Apothecon and is included in one NDA. Additional details are available on the CAPOZIDE 50/25 profile page.

The generic ingredient in CAPOZIDE 50/25 is captopril; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.

Summary for NDA: 018709

Tradename:
CAPOZIDE 25/15
Applicant:
Apothecon
Ingredient:
captopril; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 12, 1984TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 12, 1984TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 12, 1984TE:RLD:No

Expired Orange Book Patents for NDA: 018709

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apothecon
CAPOZIDE 50/25
captopril; hydrochlorothiazide
TABLET;ORAL018709-003Oct 12, 19844,105,776► subscribe
Apothecon
CAPOZIDE 50/25
captopril; hydrochlorothiazide
TABLET;ORAL018709-003Oct 12, 19844,217,347► subscribe
Apothecon
CAPOZIDE 25/15
captopril; hydrochlorothiazide
TABLET;ORAL018709-001Oct 12, 19844,105,776► subscribe
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