Documents
Application Sponsors
| NDA 018118 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | CAPSULE;ORAL | 0.2MG | 0 | LANOXICAPS | DIGOXIN |
| 002 | CAPSULE;ORAL | 0.05MG | 0 | LANOXICAPS | DIGOXIN |
| 003 | CAPSULE;ORAL | 0.1MG | 0 | LANOXICAPS | DIGOXIN |
| 004 | CAPSULE;ORAL | 0.15MG | 0 | LANOXICAPS | DIGOXIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1982-07-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1984-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1986-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1984-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1984-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1986-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1984-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1986-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1987-05-22 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1989-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1992-05-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-08-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1994-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1994-04-28 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1996-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1998-07-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-10-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | 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 |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 18118
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"LANOXICAPS","activeIngredients":"DIGOXIN","strength":"0.2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANOXICAPS","activeIngredients":"DIGOXIN","strength":"0.05MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANOXICAPS","activeIngredients":"DIGOXIN","strength":"0.1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANOXICAPS","activeIngredients":"DIGOXIN","strength":"0.15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LANOXICAPS","submission":"DIGOXIN","actionType":"0.2MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LANOXICAPS","submission":"DIGOXIN","actionType":"0.05MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LANOXICAPS","submission":"DIGOXIN","actionType":"0.1MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LANOXICAPS","submission":"DIGOXIN","actionType":"0.15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)