Application Sponsors
| NDA 050285 | PHARMACIA AND UPJOHN | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | EQ 87.5MG BASE/5ML | 0 | MYCIFRADIN | NEOMYCIN SULFATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2009-03-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 2 | AP | 1988-07-11 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1971-02-23 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1971-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1971-03-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1971-04-26 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1971-11-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1972-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1972-04-19 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1972-04-26 | |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-03-13 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1972-06-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1973-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1974-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1974-05-01 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1974-05-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1974-11-11 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1975-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1975-01-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1975-07-01 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1975-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1976-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1978-01-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1978-05-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1979-02-27 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1979-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1981-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1982-02-05 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1984-08-23 | |
| LABELING; Labeling | SUPPL | 30 | AP | 1984-08-23 | |
| LABELING; Labeling | SUPPL | 31 | AP | 1992-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1994-02-22 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1994-10-28 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 32 | Null | 0 |
CDER Filings
PHARMACIA AND UPJOHN
cder:Array
(
[0] => Array
(
[ApplNo] => 50285
[companyName] => PHARMACIA AND UPJOHN
[docInserts] => ["",""]
[products] => [{"drugName":"MYCIFRADIN","activeIngredients":"NEOMYCIN SULFATE","strength":"EQ 87.5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MYCIFRADIN","submission":"NEOMYCIN SULFATE","actionType":"EQ 87.5MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)