Application Sponsors
| ANDA 076560 | NEXGEN PHARMA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 325MG;50MG;40MG;30MG | 0 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
| 002 | CAPSULE;ORAL | 300MG;50MG;40MG;30MG | 0 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 2004-06-10 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-07-19 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2012-07-19 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2011-10-21 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-03-25 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 2018-09-18 | |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
LGM PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 76560
[companyName] => LGM PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"300MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","actionType":"325MG;50MG;40MG;30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","actionType":"300MG;50MG;40MG;30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)