Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085055
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYLENOL W/ CODEINE NO. 1 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;7.5MG TABLET;ORAL Discontinued None No No
TYLENOL W/ CODEINE NO. 2 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Discontinued None No No
TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription AA No Yes
TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/17/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-64 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/06/2019 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-60 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-59 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/24/2017 SUPPL-58 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

05/06/2019 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

08/15/2014 SUPPL-54 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-53 Labeling-Package Insert

Label is not available on this site.

09/15/2011 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

07/11/2008 SUPPL-50 Labeling

Label is not available on this site.

10/31/2007 SUPPL-49 Labeling

Label is not available on this site.

05/31/2001 SUPPL-46 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2000 SUPPL-44 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2000 SUPPL-43 Manufacturing (CMC)-Facility

Label is not available on this site.

09/23/1994 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/12/1992 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/07/1991 SUPPL-35 Labeling

Label is not available on this site.

03/15/1991 SUPPL-34 Labeling

Label is not available on this site.

08/31/1990 SUPPL-32 Labeling

Label is not available on this site.

08/31/1990 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/31/1990 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/23/1988 SUPPL-29 Labeling

Label is not available on this site.

12/04/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/04/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/04/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/21/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/21/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/11/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/08/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/08/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/08/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/08/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/30/1981 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

TYLENOL W/ CODEINE NO. 1

There are no Therapeutic Equivalents.

TYLENOL W/ CODEINE NO. 2

There are no Therapeutic Equivalents.

TYLENOL W/ CODEINE NO. 3

TABLET;ORAL; 300MG;30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040779 AMNEAL PHARMS NY
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 212418 ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 211610 EYWA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040419 SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 085868 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 088628 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 089805 VINTAGE
TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 085055 JANSSEN PHARMS

TYLENOL W/ CODEINE NO. 4

TABLET;ORAL; 300MG;60MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 212418 ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 211610 EYWA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 040419 SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 087083 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 088629 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 089828 VINTAGE PHARMS
TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 085055 JANSSEN PHARMS

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