Application Sponsors
| ANDA 081297 | BIONPHARMA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 100MG | 0 | BENZONATATE | BENZONATATE |
| 002 | CAPSULE;ORAL | 200MG | 0 | BENZONATATE | BENZONATATE |
FDA Submissions
| ORIG | 1 | AP | 1993-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-05-03 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1993-09-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-10-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-10-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-12-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2002-08-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-08-29 | |
| LABELING; Labeling | SUPPL | 14 | AP | 2002-08-29 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2007-10-30 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2011-04-20 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 81297
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)