Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION/DROPS;OPHTHALMIC | 1% | 0 | ACHROMYCIN | TETRACYCLINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 1955-11-23 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1983-03-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1983-06-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1983-06-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-05-23 | |
LABELING; Labeling | SUPPL | 7 | AP | 1961-03-17 | |
LABELING; Labeling | SUPPL | 8 | AP | 1986-06-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1962-02-20 | |
LABELING; Labeling | SUPPL | 10 | AP | 1961-10-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-06-28 | |
LABELING; Labeling | SUPPL | 13 | AP | 1962-02-20 | |
LABELING; Labeling | SUPPL | 14 | AP | 1963-05-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1965-03-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1965-10-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1968-11-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1970-06-12 | |
LABELING; Labeling | SUPPL | 19 | AP | 1972-07-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1974-01-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1974-05-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1974-08-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1975-06-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1975-04-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1975-10-06 | |
LABELING; Labeling | SUPPL | 26 | AP | 1975-12-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1981-03-20 | |
LABELING; Labeling | SUPPL | 28 | AP | 1981-07-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1982-03-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1988-12-01 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | 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 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 30 | Null | 0 |
CDER Filings
STORZ
cder:Array
(
[0] => Array
(
[ApplNo] => 50268
[companyName] => STORZ
[docInserts] => ["",""]
[products] => [{"drugName":"ACHROMYCIN","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"1%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACHROMYCIN","submission":"TETRACYCLINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)