Application Sponsors
| ANDA 063181 | WATSON LABS TEVA | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | EQ 50MG BASE | 0 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1991-12-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1996-03-04 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1996-05-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-11-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1999-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-04-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-10-16 | |
| LABELING; Labeling | SUPPL | 18 | AP | 2001-10-16 | |
| LABELING; Labeling | SUPPL | 36 | AP | 2008-05-29 | |
| LABELING; Labeling | SUPPL | 40 | AP | 2008-11-20 | |
| LABELING; Labeling | SUPPL | 52 | AP | 2020-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 53 | AP | 2020-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2020-05-05 | STANDARD |
Submissions Property Types
| SUPPL | 1 | 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 | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 52 | Null | 15 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 54 | Null | 7 |
TE Codes
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 63181
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"MINOCYCLINE HYDROCHLORIDE","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MINOCYCLINE HYDROCHLORIDE","submission":"MINOCYCLINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)