Application Sponsors
| ANDA 040500 | PERRIGO ISRAEL | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SUPPOSITORY;RECTAL | 12.5MG | 0 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE |
| 002 | SUPPOSITORY;RECTAL | 25MG | 0 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2003-06-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2005-06-09 | |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
PERRIGO ISRAEL
cder:Array
(
[0] => Array
(
[ApplNo] => 40500
[companyName] => PERRIGO ISRAEL
[docInserts] => ["",""]
[products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)