Application Sponsors
| ANDA 085740 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 25MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1977-07-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1982-05-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1987-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1987-06-24 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1988-05-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1989-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1989-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1989-04-18 | |
| BIOEQUIV; Bioequivalence | SUPPL | 23 | AP | 1989-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1997-05-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1998-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1998-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1999-04-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1999-04-13 | |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | 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 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 85740
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)