TYLENOL W/ CODEINE |
085057 |
001 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
SOLUTION;ORAL |
120MG/5ML;12MG/5ML |
Yes
|
No
|
--
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL |
017756 |
001 |
NDA |
ACETAMINOPHEN |
SUPPOSITORY;RECTAL |
650MG |
No
|
No
|
1976/05/26
|
Approved Prior to Jan 1, 1982
|
J AND J CONSUMER INC |
Discontinued |
TYLENOL |
017756 |
002 |
NDA |
ACETAMINOPHEN |
SUPPOSITORY;RECTAL |
120MG |
No
|
No
|
1976/05/26
|
Approved Prior to Jan 1, 1982
|
J AND J CONSUMER INC |
Discontinued |
TYLENOL W/ CODEINE |
085056 |
001 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
1976/07/09
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL W/ CODEINE |
085056 |
002 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
1976/07/09
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL W/ CODEINE |
085056 |
003 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
1976/07/09
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL W/ CODEINE |
085056 |
004 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
No
|
No
|
1976/07/09
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL W/ CODEINE NO. 1 |
085055 |
001 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;7.5MG |
No
|
No
|
1977/08/17
|
Approved Prior to Jan 1, 1982
|
JANSSEN PHARMS |
Discontinued |
TYLENOL W/ CODEINE NO. 2 |
085055 |
002 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Yes
|
No
|
1977/08/17
|
Approved Prior to Jan 1, 1982
|
JANSSEN PHARMS |
Discontinued |
TYLENOL W/ CODEINE NO. 3 |
085055 |
003 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Yes
|
No
|
1977/08/17
|
Approved Prior to Jan 1, 1982
|
JANSSEN PHARMS |
Discontinued |
TYLENOL W/ CODEINE NO. 4 |
085055 |
004 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Yes
|
No
|
1977/08/17
|
Approved Prior to Jan 1, 1982
|
JANSSEN PHARMS |
Discontinued |
TYLENOL W/ CODEINE NO. 4 |
087421 |
001 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
CAPSULE;ORAL |
300MG;60MG |
No
|
No
|
1981/09/29
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL W/ CODEINE NO. 3 |
087422 |
001 |
ANDA |
ACETAMINOPHEN; CODEINE PHOSPHATE |
CAPSULE;ORAL |
300MG;30MG |
No
|
No
|
1981/09/29
|
Approved Prior to Jan 1, 1982
|
ORTHO MCNEIL PHARM |
Discontinued |
TYLENOL |
019872 |
001 |
NDA |
ACETAMINOPHEN |
TABLET, EXTENDED RELEASE;ORAL |
650MG |
Yes
|
Yes
|
1994/06/08
|
1994/06/08
|
KENVUE BRANDS |
Over-the-counter |
TYLENOL |
019872 |
002 |
NDA |
ACETAMINOPHEN |
TABLET, EXTENDED RELEASE;ORAL |
650MG |
Yes
|
Yes
|
1994/06/08
|
2001/01/11
|
KENVUE BRANDS |
Over-the-counter |