Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 004 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PLENDIL | FELODIPINE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PLENDIL | FELODIPINE |
| 004 | TABLET, EXTENDED RELEASE;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | PLENDIL | FELODIPINE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1991-07-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1994-09-22 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 1995-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-02-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-07-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1998-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1997-10-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1998-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2000-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2000-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2002-05-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-09-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2004-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2012-10-31 | UNKNOWN |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 25 | Null | 6 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 19834
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"PLENDIL","activeIngredients":"FELODIPINE","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PLENDIL","activeIngredients":"FELODIPINE","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PLENDIL","activeIngredients":"FELODIPINE","strength":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/31\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019834s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2004","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19834slr022_plendil_lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2002","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19834s17lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/1998","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/19834S009_PLENDIL_PRNTLBL.PDF\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PLENDIL","submission":"FELODIPINE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PLENDIL","submission":"FELODIPINE","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PLENDIL","submission":"FELODIPINE","actionType":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-10-31
)
)