Application Sponsors
| NDA 050339 | PHARMACIA AND UPJOHN | |
Marketing Status
Application Products
| 001 | CAPSULE; ORAL | EQ 250MG BASE | 0 | ALBAMYCIN | NOVOBIOCIN SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1964-09-04 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1964-10-08 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1964-11-06 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1965-01-22 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1966-02-25 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1966-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1966-11-25 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1966-12-15 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1967-03-20 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1967-08-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1968-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1969-03-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1969-06-05 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1969-08-05 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1969-06-30 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1969-10-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1969-11-14 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1969-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1970-03-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1970-02-10 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1970-03-27 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1970-04-20 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1970-07-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1970-10-12 | |
| LABELING; Labeling | SUPPL | 25 | AP | 1971-12-17 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1972-05-04 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1973-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1973-06-08 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1974-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1975-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1976-11-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1978-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1979-04-03 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1979-04-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1982-02-22 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1982-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1982-08-24 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
CDER Filings
PHARMACIA AND UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 50339
[companyName] => PHARMACIA AND UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"ALBAMYCIN","activeIngredients":"NOVOBIOCIN SODIUM","strength":"EQ 250MG BASE","dosageForm":"CAPSULE; ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ALBAMYCIN","submission":"NOVOBIOCIN SODIUM","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE; ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)