Application Sponsors
ANDA 062816 | WATSON LABS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Discontinued | 005 |
Application Products
001 | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | 0 | AMPICILLIN SODIUM | AMPICILLIN SODIUM |
002 | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | 0 | AMPICILLIN SODIUM | AMPICILLIN SODIUM |
003 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 0 | AMPICILLIN SODIUM | AMPICILLIN SODIUM |
004 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | AMPICILLIN SODIUM | AMPICILLIN SODIUM |
005 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | AMPICILLIN SODIUM | AMPICILLIN SODIUM |
FDA Submissions
| ORIG | 1 | AP | 1988-10-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-11-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-12-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-01-23 | |
LABELING; Labeling | SUPPL | 9 | AP | 1990-12-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-11-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-11-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1993-11-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1994-01-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1995-01-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-06-23 | |
LABELING; Labeling | SUPPL | 17 | AP | 1996-03-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1996-04-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1997-07-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1997-12-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1999-11-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-12-08 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 22 | Null | 0 |
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 62816
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 125MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 125MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)