Application Sponsors
| ANDA 085055 | JANSSEN PHARMS | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 300MG;7.5MG | 0 | TYLENOL W/ CODEINE NO. 1 | ACETAMINOPHEN; CODEINE PHOSPHATE |
| 002 | TABLET;ORAL | 300MG;15MG | 0 | TYLENOL W/ CODEINE NO. 2 | ACETAMINOPHEN; CODEINE PHOSPHATE |
| 003 | TABLET;ORAL | 300MG;30MG | 0 | TYLENOL W/ CODEINE NO. 3 | ACETAMINOPHEN; CODEINE PHOSPHATE |
| 004 | TABLET;ORAL | 300MG;60MG | 0 | TYLENOL W/ CODEINE NO. 4 | ACETAMINOPHEN; CODEINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 1977-08-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1981-12-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1982-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1982-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-12-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1983-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1983-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1983-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1986-12-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1986-12-04 | |
| LABELING; Labeling | SUPPL | 29 | AP | 1988-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1990-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1990-08-31 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1990-08-31 | |
| LABELING; Labeling | SUPPL | 34 | AP | 1991-03-15 | |
| LABELING; Labeling | SUPPL | 35 | AP | 1991-05-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1992-11-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1993-09-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1994-09-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2000-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2000-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 2001-05-31 | |
| LABELING; Labeling | SUPPL | 49 | AP | 2007-10-31 | |
| LABELING; Labeling | SUPPL | 50 | AP | 2008-07-11 | |
| LABELING; Labeling | SUPPL | 52 | AP | 2011-09-15 | |
| LABELING; Labeling | SUPPL | 53 | AP | 2013-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2014-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2019-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2017-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2017-08-29 | STANDARD |
| REMS; REMS | SUPPL | 60 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 61 | AP | 2018-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2019-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 63 | AP | 2019-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2019-10-29 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 54 | Null | 15 |
| SUPPL | 56 | Null | 15 |
| SUPPL | 57 | Null | 15 |
| SUPPL | 58 | Null | 15 |
| SUPPL | 59 | Null | 7 |
| SUPPL | 60 | Null | 7 |
| SUPPL | 61 | Null | 7 |
| SUPPL | 62 | Null | 15 |
| SUPPL | 63 | Null | 15 |
| SUPPL | 64 | Null | 7 |
TE Codes
| 003 | Prescription | AA |
| 004 | Prescription | AA |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 85055
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TYLENOL W\/ CODEINE NO. 1","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TYLENOL W\/ CODEINE NO. 2","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TYLENOL W\/ CODEINE NO. 3","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TYLENOL W\/ CODEINE NO. 4","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TYLENOL W\/ CODEINE NO. 1","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TYLENOL W\/ CODEINE NO. 2","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TYLENOL W\/ CODEINE NO. 3","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TYLENOL W\/ CODEINE NO. 4","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)