Documents
Application Sponsors
ANDA 063014 | WATSON LABS INC | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 5,000,000 UNITS/VIAL | 0 | PENICILLIN G SODIUM | PENICILLIN G SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1988-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-12-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-02-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-01-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1989-02-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-11-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-12-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-01-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-05-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1994-05-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-01-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-02-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-12-08 | |
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 | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 63014
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PENICILLIN G SODIUM","activeIngredients":"PENICILLIN G SODIUM","strength":"5,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PENICILLIN G SODIUM","submission":"PENICILLIN G SODIUM","actionType":"5,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)