Details for New Drug Application (NDA): 019834
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The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 019834
Tradename: | PLENDIL |
Applicant: | Astrazeneca |
Ingredient: | felodipine |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019834
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 25, 1991 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 25, 1991 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 22, 1994 | TE: | RLD: | Yes |
Expired US Patents for NDA 019834
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-004 | Sep 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-004 | Sep 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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