Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022202
Company: ASSERTIO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZIPSOR DICLOFENAC POTASSIUM 25MG CAPSULE;ORAL 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
06/16/2009 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/2009/022202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022202s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022202_zipsor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022202s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-11 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022202Orig1s011ltr.pdf
12/16/2015 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

08/07/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/04/2011 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003,s004ltr.pdf
05/04/2011 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003s,s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf
05/09/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf
05/09/2016 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022202s011lbl.pdf
06/16/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022202lbl.pdf

ZIPSOR

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 25MG CAPSULE;ORAL Prescription No AB 204648 BIONPHARMA INC
ZIPSOR DICLOFENAC POTASSIUM 25MG CAPSULE;ORAL Prescription Yes AB 022202 ASSERTIO

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