Application Sponsors
| ANDA 074416 | PIRAMAL CRITICAL | |
Marketing Status
Application Products
| 001 | LIQUID;INHALATION | 99.9% | 0 | ISOFLURANE | ISOFLURANE |
FDA Submissions
| ORIG | 1 | AP | 1994-09-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2000-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-06-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-01-03 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-02-06 | |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 7 |
TE Codes
CDER Filings
PIRAMAL CRITICAL
cder:Array
(
[0] => Array
(
[ApplNo] => 74416
[companyName] => PIRAMAL CRITICAL
[docInserts] => ["",""]
[products] => [{"drugName":"ISOFLURANE","activeIngredients":"ISOFLURANE","strength":"99.9%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ISOFLURANE","submission":"ISOFLURANE","actionType":"99.9%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)