Application Sponsors
Marketing Status
Application Products
| 003 | TABLET;ORAL | 25MG | 0 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1975-03-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1982-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1982-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1982-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1982-03-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1982-03-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1982-03-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 71 | AP | 1982-03-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 1984-01-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 74 | AP | 1984-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1984-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 1984-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1984-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 1984-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 80 | AP | 1985-03-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 82 | AP | 1987-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 85 | AP | 1986-04-24 | |
| LABELING; Labeling | SUPPL | 87 | AP | 1989-05-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 90 | AP | 1996-04-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 91 | AP | 1995-11-07 | |
| LABELING; Labeling | SUPPL | 93 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 94 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 95 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 96 | AP | 1999-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 97 | AP | 1999-05-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 98 | AP | 2001-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 99 | AP | 2002-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 100 | AP | 2002-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 106 | AP | 2007-06-19 | |
Submissions Property Types
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 71 | Null | 0 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 74 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 79 | Null | 0 |
| SUPPL | 80 | Null | 0 |
| SUPPL | 82 | Null | 0 |
| SUPPL | 85 | Null | 0 |
| SUPPL | 90 | Null | 0 |
| SUPPL | 91 | Null | 0 |
| SUPPL | 94 | Null | 0 |
| SUPPL | 95 | Null | 0 |
| SUPPL | 96 | Null | 0 |
| SUPPL | 97 | Null | 0 |
| SUPPL | 98 | Null | 0 |
| SUPPL | 99 | Null | 0 |
| SUPPL | 100 | Null | 0 |
| SUPPL | 106 | Null | 0 |
TE Codes
CDER Filings
INVATECH
cder:Array
(
[0] => Array
(
[ApplNo] => 84092
[companyName] => INVATECH
[docInserts] => ["",""]
[products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)