Details for New Drug Application (NDA): 018343
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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: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | 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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