Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205901
Company: HETERO LABS LTD V

Products on ANDA 205901

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Discontinued	None	No	No
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Discontinued	None	No	No
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205901

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205901Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205901Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/16/2020	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.
07/16/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 205901

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205901Orig1s000lbl.pdf