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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200671
Company: HESP

Products on NDA 200671

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DURLAZA	ASPIRIN	162.5MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200671

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

Labels for NDA 200671

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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