Application Sponsors
ANDA 070663 | YAOPHARMA CO LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | 10MG | 0 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-06-13 | |
LABELING; Labeling | SUPPL | 2 | AP | 1986-11-19 | |
LABELING; Labeling | SUPPL | 3 | AP | 1986-12-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-12-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-12-22 | |
LABELING; Labeling | SUPPL | 6 | AP | 1988-12-22 | |
LABELING; Labeling | SUPPL | 7 | AP | 1987-07-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-02-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-12-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-12-22 | |
LABELING; Labeling | SUPPL | 11 | AP | 1988-11-29 | |
LABELING; Labeling | SUPPL | 12 | AP | 1989-07-10 | |
LABELING; Labeling | SUPPL | 13 | AP | 1992-05-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-05-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-05-09 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 70663
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)