Application Sponsors
ANDA 062991 | WATSON LABS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | INJECTABLE;INJECTION | 1,000,000 UNITS/VIAL | 0 | PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM |
002 | INJECTABLE;INJECTION | 5,000,000 UNITS/VIAL | 0 | PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM |
003 | INJECTABLE;INJECTION | 10,000,000 UNITS/VIAL | 0 | PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM |
004 | INJECTABLE;INJECTION | 20,000,000 UNITS/VIAL | 0 | PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM |
FDA Submissions
| ORIG | 1 | AP | 1988-09-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-12-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-02-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-02-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-01-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-07-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-11-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1993-11-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-01-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-01-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-01-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-06-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-01-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-05-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | 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 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 62991
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"1,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"5,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"10,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PENICILLIN G POTASSIUM","activeIngredients":"PENICILLIN G POTASSIUM","strength":"20,000,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"1,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"5,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"10,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PENICILLIN G POTASSIUM","submission":"PENICILLIN G POTASSIUM","actionType":"20,000,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)