Application Sponsors
| ANDA 088763 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
| 001 | SYRUP;ORAL | 10MG/5ML;6.25MG/5ML | 0 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-08-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-10-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1987-02-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1987-03-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-03-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1988-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1988-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1989-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1989-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1989-06-21 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1989-11-03 | |
| LABELING; Labeling | SUPPL | 19 | AP | 1990-08-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1990-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1993-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1993-08-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1994-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1996-05-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1996-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1996-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1995-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1996-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-05-07 | |
| LABELING; Labeling | SUPPL | 33 | AP | 1996-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1996-06-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1996-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1997-09-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1998-12-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1998-12-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2000-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 2001-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2001-10-03 | |
| LABELING; Labeling | SUPPL | 47 | AP | 2003-06-06 | |
| LABELING; Labeling | SUPPL | 54 | AP | 2005-05-02 | |
| LABELING; Labeling | SUPPL | 60 | AP | 2005-10-06 | |
| LABELING; Labeling | SUPPL | 74 | AP | 2008-12-19 | |
| LABELING; Labeling | SUPPL | 78 | AP | 2009-08-27 | |
| LABELING; Labeling | SUPPL | 83 | AP | 2014-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 86 | AP | 2017-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 87 | AP | 2017-08-29 | STANDARD |
| LABELING; Labeling | SUPPL | 88 | AP | 2018-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 89 | AP | 2018-06-28 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 78 | Null | 7 |
| SUPPL | 83 | Null | 15 |
| SUPPL | 86 | Null | 7 |
| SUPPL | 87 | Null | 7 |
| SUPPL | 88 | Null | 7 |
| SUPPL | 89 | Null | 15 |
TE Codes
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 88763
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE","activeIngredients":"CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE","strength":"10MG\/5ML;6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE","submission":"CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE","actionType":"10MG\/5ML;6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)