An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 210238
Company: AKARX INC

Products on NDA 210238

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOPTELET	AVATROMBOPAG MALEATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210238

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210238s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210238Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210238Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210238s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210238Orig1s009ltr.pdf
10/14/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210238s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210238Orig1s006ltr.pdf
08/20/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210238s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210238Orig1s004ltr.pdf
03/21/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210238s002lbl.pdf
06/26/2019	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210238s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210238Orig1s001ltr.pdf

Labels for NDA 210238

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210238s009lbl.pdf
10/14/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210238s006lbl.pdf
08/20/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210238s004lbl.pdf
06/26/2019	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210238s001lbl.pdf
03/21/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210238s002lbl.pdf
05/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210238s000lbl.pdf

Top