Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 2.5MG/ML | 1 | INAPSINE | DROPERIDOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1970-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1974-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1976-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1980-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1982-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1982-07-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1982-01-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1982-08-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1987-12-31 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1987-12-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1985-03-15 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 1987-04-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1986-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 1986-12-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-12-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1987-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1990-10-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1992-10-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1994-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 1994-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1995-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1995-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1998-09-29 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2000-02-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2000-04-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2000-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2001-11-26 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
TE Codes
CDER Filings
AKORN INC
cder:Array
(
[0] => Array
(
[ApplNo] => 16796
[companyName] => AKORN INC
[docInserts] => ["",""]
[products] => [{"drugName":"INAPSINE","activeIngredients":"DROPERIDOL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"INAPSINE","submission":"DROPERIDOL","actionType":"2.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)