Application Sponsors
| ANDA 086727 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 0.025MG;2.5MG | 0 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1979-10-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1987-01-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1987-01-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1988-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-01-20 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1998-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1999-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1999-11-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1999-11-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1999-11-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2000-05-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-05-05 | |
| LABELING; Labeling | SUPPL | 34 | AP | 2000-05-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2000-08-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2001-09-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2002-07-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2007-06-19 | |
Submissions Property Types
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 44 | Null | 0 |
TE Codes
CDER Filings
ANI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 86727
[companyName] => ANI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","strength":"0.025MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","submission":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","actionType":"0.025MG;2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)