Application Sponsors
| ANDA 080448 | SUN PHARM INDUSTRIES | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 100MG | 0 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1976-10-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1983-10-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1986-08-14 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1989-03-16 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1992-05-08 | |
| REMS; REMS | SUPPL | 21 | AP | 2018-09-18 | |
Submissions Property Types
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 21 | Null | 7 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 80448
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"MEPERIDINE HYDROCHLORIDE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEPERIDINE HYDROCHLORIDE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MEPERIDINE HYDROCHLORIDE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEPERIDINE HYDROCHLORIDE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)