Application Sponsors
| NDA 050594 | JOHNSON AND JOHNSON | |
Marketing Status
Application Products
| 001 | SWAB;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ERYCETTE | ERYTHROMYCIN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1985-02-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1987-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-07-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-09-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1986-10-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1987-10-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1987-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1990-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1992-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1993-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1995-06-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-12-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1997-04-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-07-23 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
CDER Filings
JOHNSON AND JOHNSON
cder:Array
(
[0] => Array
(
[ApplNo] => 50594
[companyName] => JOHNSON AND JOHNSON
[docInserts] => ["",""]
[products] => [{"drugName":"ERYCETTE","activeIngredients":"ERYTHROMYCIN","strength":"2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SWAB;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ERYCETTE","submission":"ERYTHROMYCIN","actionType":"2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)