Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019111
Company: UCB INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TUSSIONEX PENNKINETIC CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION, EXTENDED RELEASE;ORAL Discontinued None Yes No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
12/31/1987 ORIG-1 Approval Type 4 - New Combination 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
06/28/2018 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019111Orig1s022ltr.pdf
01/13/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019111s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019111Orig1s019ltr.pdf
04/01/2015 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019111Orig1s018ltr.pdf
03/21/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/02/2011 SUPPL-16 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019111s016ltr.pdf
03/11/2008 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019111s015ltr.pdf
11/12/2003 SUPPL-11 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19111slr011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019111_s011_TUSSIONEX KINETIC.pdf
06/07/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/29/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/27/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1993 SUPPL-3 Labeling

Label is not available on this site.

11/26/1993 SUPPL-2 Labeling

Label is not available on this site.

12/20/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf
01/13/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019111s019lbl.pdf
04/01/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf
04/01/2015 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf
03/11/2008 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf

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