Application Sponsors
ANDA 070548 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 10MG | 0 | PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-07-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1987-02-05 | |
LABELING; Labeling | SUPPL | 3 | AP | 1987-08-10 | |
LABELING; Labeling | SUPPL | 4 | AP | 1988-12-22 | |
LABELING; Labeling | SUPPL | 5 | AP | 1990-02-28 | |
LABELING; Labeling | SUPPL | 6 | AP | 1990-07-26 | |
LABELING; Labeling | SUPPL | 7 | AP | 1990-09-10 | |
LABELING; Labeling | SUPPL | 11 | AP | 1991-02-04 | |
LABELING; Labeling | SUPPL | 12 | AP | 1992-06-04 | |
LABELING; Labeling | SUPPL | 13 | AP | 1999-02-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-11-10 | |
LABELING; Labeling | SUPPL | 15 | AP | 1999-11-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-08-31 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 70548
[companyName] => WATSON LABS TEVA
[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
)
)