Application Sponsors
| ANDA 085953 | ACTAVIS MID ATLANTIC | |
Marketing Status
Application Products
| 001 | SYRUP;ORAL | 6.25MG/5ML | 0 | PROMETH PLAIN | PROMETHAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1978-08-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1983-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1986-02-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1989-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1989-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1990-05-16 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1989-11-21 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1990-05-01 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1990-05-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1990-12-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1990-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1993-06-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1997-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1997-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1996-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1996-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1996-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1996-08-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1996-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1997-01-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1997-08-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1999-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1999-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2000-11-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 2001-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2001-10-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2001-10-03 | |
Submissions Property Types
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
CDER Filings
ACTAVIS MID ATLANTIC
cder:Array
(
[0] => Array
(
[ApplNo] => 85953
[companyName] => ACTAVIS MID ATLANTIC
[docInserts] => ["",""]
[products] => [{"drugName":"PROMETH PLAIN","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"6.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROMETH PLAIN","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"6.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)