Application Sponsors
| ANDA 070044 | WATSON LABS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | METRONIDAZOLE | METRONIDAZOLE |
FDA Submissions
| ORIG | 1 | AP | 1985-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-09-25 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1987-09-23 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1990-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1990-07-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1990-07-14 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1991-08-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-04-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1993-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1993-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1993-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1993-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1993-07-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1993-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1994-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1994-04-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1994-01-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1994-01-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1994-01-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1995-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1995-10-03 | |
| LABELING; Labeling | SUPPL | 30 | AP | 1995-11-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1996-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1996-08-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1997-01-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1997-07-08 | |
| LABELING; Labeling | SUPPL | 36 | AP | 1997-03-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2000-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2000-07-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2001-08-30 | |
| LABELING; Labeling | SUPPL | 55 | AP | 2013-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2014-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2019-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2022-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2022-04-05 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | 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 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 55 | Null | 15 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 58 | Null | 7 |
| SUPPL | 59 | Null | 15 |
| SUPPL | 60 | Null | 15 |
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 70044
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METRONIDAZOLE","submission":"METRONIDAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)