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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 018343


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NDA 018343 describes CAPOTEN, which is a drug marketed by Strides Pharma and is included in one NDA. Additional details are available on the CAPOTEN profile page.

The generic ingredient in CAPOTEN is captopril. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the captopril profile page.
Summary for 018343
Tradename:CAPOTEN
Applicant:Strides Pharma
Ingredient:captopril
Patents:0
Medical Subject Heading (MeSH) Categories for 018343

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 018343

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Strides Pharma CAPOTEN captopril TABLET;ORAL 018343-004 Jun 13, 1995 ⤷  Sign Up ⤷  Sign Up
Strides Pharma CAPOTEN captopril TABLET;ORAL 018343-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Strides Pharma CAPOTEN captopril TABLET;ORAL 018343-003 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Strides Pharma CAPOTEN captopril TABLET;ORAL 018343-005 Jan 17, 1985 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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