Application Sponsors
| ANDA 089383 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1986-05-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1990-10-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-06-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-02-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-03-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-06-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-04-03 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2002-03-12 | |
| LABELING; Labeling | SUPPL | 28 | AP | 2014-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2016-03-30 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2016-11-08 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | 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 | 28 | Null | 7 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 33 | Null | 15 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89383
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)