Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200671
Company: ESPERO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DURLAZA ASPIRIN 162.5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription 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
09/04/2015 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/200671Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2015 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s002ltr.pdf
09/15/2015 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200671Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/2015 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s002lbl.pdf
09/15/2015 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671Orig1s001lbl.pdf
09/04/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200671s000lbl.pdf

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