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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019111
Company: UCB INC

Medication Guide

Other Important Information from FDA

Products on NDA 019111

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EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019111

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-Container/Carton Labels, Labeling-Package Insert	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.

Labels for NDA 019111

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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019111s018lbl.pdf
04/01/2015	SUPPL-18	Labeling-Package Insert	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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