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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206511
Company: AUROBINDO PHARMA

Products on ANDA 206511

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	AB	No	No
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	AB	No	No
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206511

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/2015	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206511Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/09/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/09/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/02/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206511

TELMISARTAN

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICARDIS	TELMISARTAN	20MG	TABLET;ORAL	Prescription	Yes	AB	020850	BOEHRINGER INGELHEIM
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	202130	ALEMBIC
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	204415	AMNEAL PHARMS
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	206511	AUROBINDO PHARMA
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	208605	CADILA PHARMS LTD
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	078710	CHARTWELL RX
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	090032	GLENMARK PHARMS LTD
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	205901	HETERO LABS LTD V
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	205150	INVENTIA
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	207016	MICRO LABS
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	202397	MYLAN
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	207882	PRINSTON INC
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	203867	SANDOZ
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	203325	ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICARDIS	TELMISARTAN	40MG	TABLET;ORAL	Prescription	Yes	AB	020850	BOEHRINGER INGELHEIM
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	202130	ALEMBIC
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	204415	AMNEAL PHARMS
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	206511	AUROBINDO PHARMA
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	208605	CADILA PHARMS LTD
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	078710	CHARTWELL RX
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	090032	GLENMARK PHARMS LTD
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	205901	HETERO LABS LTD V
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	205150	INVENTIA
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	207016	MICRO LABS
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	202397	MYLAN
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	207882	PRINSTON INC
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	203867	SANDOZ
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	203325	ZYDUS PHARMS

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICARDIS	TELMISARTAN	80MG	TABLET;ORAL	Prescription	Yes	AB	020850	BOEHRINGER INGELHEIM
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	202130	ALEMBIC
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	204415	AMNEAL PHARMS
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	206511	AUROBINDO PHARMA
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	208605	CADILA PHARMS LTD
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	078710	CHARTWELL RX
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	090032	GLENMARK PHARMS LTD
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	205901	HETERO LABS LTD V
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	205150	INVENTIA
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	207016	MICRO LABS
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	202397	MYLAN
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	207882	PRINSTON INC
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	203867	SANDOZ
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	203325	ZYDUS PHARMS

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