Application Sponsors
| ANDA 084678 | UPSHER SMITH LABS | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 5MG | 0 | CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1976-06-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 1982-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1982-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 1982-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 1982-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 1982-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 1982-07-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1982-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 1982-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 1983-06-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1984-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 1984-01-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 77 | AP | 1984-05-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 1985-01-08 | |
| LABELING; Labeling | SUPPL | 81 | AP | 1989-04-07 | |
| LABELING; Labeling | SUPPL | 82 | AP | 1989-11-21 | |
| LABELING; Labeling | SUPPL | 84 | AP | 1995-02-03 | |
| LABELING; Labeling | SUPPL | 88 | AP | 2016-12-16 | STANDARD |
Submissions Property Types
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 79 | Null | 0 |
| SUPPL | 88 | Null | 7 |
TE Codes
CDER Filings
UPSHER SMITH LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 84678
[companyName] => UPSHER SMITH LABS
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORDIAZEPOXIDE HYDROCHLORIDE","submission":"CHLORDIAZEPOXIDE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)