Documents
Application Sponsors
| NDA 018063 | US WORLDMEDS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET;ORAL | 40MG | 1 | CORGARD | NADOLOL |
| 002 | TABLET;ORAL | 80MG | 1 | CORGARD | NADOLOL |
| 003 | TABLET;ORAL | 120MG | 0 | CORGARD | NADOLOL |
| 004 | TABLET;ORAL | 160MG | 0 | CORGARD | NADOLOL |
| 005 | TABLET;ORAL | 20MG | 1 | CORGARD | NADOLOL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1979-12-10 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1980-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1980-08-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1981-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1980-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1980-12-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1981-03-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1981-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1981-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1981-04-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1981-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1981-07-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1981-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1981-10-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1982-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1982-04-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1982-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1982-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1982-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1982-11-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1983-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1983-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1983-07-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1983-10-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1983-11-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 1984-11-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1984-01-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1984-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1984-03-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1984-05-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 1986-10-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1984-05-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1984-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1984-08-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1984-10-24 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1985-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1986-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1986-08-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1987-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1987-01-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1990-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1987-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 1990-11-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1991-03-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1991-05-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1991-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1992-05-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1992-05-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1994-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1995-08-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1996-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2001-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2008-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2011-06-06 | UNKNOWN |
| LABELING; Labeling | SUPPL | 63 | AP | 2013-07-15 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 63 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
USWM
cder:Array
(
[0] => Array
(
[ApplNo] => 18063
[companyName] => USWM
[docInserts] => ["",""]
[products] => [{"drugName":"CORGARD","activeIngredients":"NADOLOL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"CORGARD","activeIngredients":"NADOLOL","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CORGARD","activeIngredients":"NADOLOL","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CORGARD","activeIngredients":"NADOLOL","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CORGARD","activeIngredients":"NADOLOL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"07\/15\/2013","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018063s063lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2011","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018063s062lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2008","submission":"SUPPL-60","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018063s060lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CORGARD","submission":"NADOLOL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CORGARD","submission":"NADOLOL","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CORGARD","submission":"NADOLOL","actionType":"120MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CORGARD","submission":"NADOLOL","actionType":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CORGARD","submission":"NADOLOL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2013-07-15
)
)