Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022122
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOLTAREN DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription AB 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
10/17/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/02212s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/Voltaren_022122.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022122_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2014 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

02/21/2018 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022122Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/022122Orig1s011.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022122Orig1s010ltr.pdf
05/11/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/25/2014 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022122Orig1s007ltr.pdf
09/23/2009 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022122s006ltr.pdf
09/04/2009 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/07/2010 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/21/2018 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf
02/21/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
05/09/2016 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf
11/25/2014 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf
09/23/2009 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf
10/17/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf

VOLTAREN

GEL;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 208077 AMNEAL PHARMS
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 209903 CIPLA
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 209484 HI TECH
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 204306 MYLAN
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription No AB 211253 PERRIGO UK FINCO
VOLTAREN DICLOFENAC SODIUM 1% GEL;TOPICAL Prescription Yes AB 022122 GLAXOSMITHKLINE CONS

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