Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019872
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes Yes
TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/08/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2019 SUPPL-48 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019872Orig1s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019872Orig1s048ltr.pdf
08/26/2016 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019872Orig1s044lbl.pdf
05/05/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/23/2014 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s042ltr.pdf
12/12/2014 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s041ltr.pdf
03/06/2014 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019872Orig1s040ltr.pdf
12/20/2013 SUPPL-39 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s039ltr.pdf
03/28/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-37 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019872Orig1s037ltr.pdf
12/23/2011 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019872s36ltr.pdf
05/10/2010 SUPPL-34 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s034ltr.pdf
05/06/2010 SUPPL-33 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019872s033ltr.pdf
09/18/2009 SUPPL-32 Labeling-Container/Carton Labels

Label is not available on this site.

06/17/2009 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019872s031ltr.pdf
02/28/2008 SUPPL-29 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019872Orig1_s029.pdf
11/03/2004 SUPPL-21 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872s021ltr.pdf
04/13/2004 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872slr018ltr.pdf
03/22/2004 SUPPL-17 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19872scp017ltr.pdf
08/01/2003 SUPPL-16 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872scs016ltr.pdf
05/28/2003 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr014ltr.pdf
05/28/2003 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr013ltr.pdf
05/29/2003 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19872slr012ltr.pdf
02/12/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/25/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/25/2000 SUPPL-9 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019872Orig1s009.pdf
01/11/2001 SUPPL-6 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019872Orig1s006.pdf
08/01/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1995 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/23/1994 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/16/2019 SUPPL-48 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019872Orig1s048lbl.pdf
08/26/2016 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019872Orig1s044lbl.pdf
12/23/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s042lbl.pdf
12/12/2014 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf
03/06/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf
12/20/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf
12/20/2013 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf
03/26/2013 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s037lbl.pdf
12/23/2011 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019872Orig1s036lbl.pdf
06/17/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf
05/29/2003 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf
05/28/2003 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf
05/28/2003 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf

TYLENOL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207229 AUROBINDO PHARMA LTD
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207035 HERITAGE PHARMA
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076200 OHM LABS
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075077 PERRIGO
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 078569 SUN PHARM INDS LTD
TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 019872 J AND J CONSUMER INC

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 650MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207229 AUROBINDO PHARMA LTD
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 207035 HERITAGE PHARMA
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 076200 OHM LABS
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075077 PERRIGO
ACETAMINOPHEN ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 078569 SUN PHARM INDS LTD
TYLENOL ACETAMINOPHEN 650MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 019872 J AND J CONSUMER INC

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