Application Sponsors
ANDA 080615 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 50MG/ML | 0 | DIMENHYDRINATE | DIMENHYDRINATE |
FDA Submissions
| ORIG | 1 | AP | 1974-01-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 154 | AP | 1982-04-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 157 | AP | 1986-05-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 159 | AP | 1988-09-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 161 | AP | 1988-08-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 162 | AP | 1988-08-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 164 | AP | 1989-03-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 165 | AP | 1989-09-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 166 | AP | 1989-09-27 | |
LABELING; Labeling | SUPPL | 167 | AP | 1991-01-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 168 | AP | 1996-08-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 169 | AP | 1999-02-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 170 | AP | 1998-11-02 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 171 | AP | 1999-02-19 | |
Submissions Property Types
SUPPL | 154 | Null | 0 |
SUPPL | 157 | Null | 0 |
SUPPL | 159 | Null | 0 |
SUPPL | 161 | Null | 0 |
SUPPL | 162 | Null | 0 |
SUPPL | 163 | Null | 0 |
SUPPL | 164 | Null | 0 |
SUPPL | 165 | Null | 0 |
SUPPL | 166 | Null | 0 |
SUPPL | 168 | Null | 0 |
SUPPL | 169 | Null | 0 |
SUPPL | 170 | Null | 0 |
SUPPL | 171 | Null | 0 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 80615
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"DIMENHYDRINATE","activeIngredients":"DIMENHYDRINATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIMENHYDRINATE","submission":"DIMENHYDRINATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)