Application Sponsors
| ANDA 080704 | BIONPHARMA INC | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 50,000 IU | 0 | VITAMIN D | ERGOCALCIFEROL |
FDA Submissions
| ORIG | 1 | AP | 1978-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-03-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1985-03-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1985-03-22 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1989-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1995-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1997-01-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1995-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-08-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1996-08-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1996-08-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1998-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2001-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2001-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2001-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 2001-10-24 | |
| LABELING; Labeling | SUPPL | 41 | AP | 2001-10-24 | |
| LABELING; Labeling | SUPPL | 43 | AP | 2008-07-24 | |
Submissions Property Types
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | 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 | 40 | Null | 0 |
TE Codes
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 80704
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"VITAMIN D","activeIngredients":"ERGOCALCIFEROL","strength":"50,000 IU","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VITAMIN D","submission":"ERGOCALCIFEROL","actionType":"50,000 IU","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)