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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202397
Company: MYLAN

Products on ANDA 202397

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 202397

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2023	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/14/2023	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/17/2019	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/19/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-1	Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202397

TELMISARTAN

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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	205150	INVENTIA
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	204164	JUBILANT GENERICS
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	203986	MACLEODS PHARMS LTD
TELMISARTAN	TELMISARTAN	20MG	TABLET;ORAL	Prescription	No	AB	218157	MANKIND PHARMA
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	203171	TORRENT
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	205150	INVENTIA
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	204164	JUBILANT GENERICS
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	203986	MACLEODS PHARMS LTD
TELMISARTAN	TELMISARTAN	40MG	TABLET;ORAL	Prescription	No	AB	218157	MANKIND PHARMA
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	203171	TORRENT
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
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	205150	INVENTIA
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	204164	JUBILANT GENERICS
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	203986	MACLEODS PHARMS LTD
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	218157	MANKIND PHARMA
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	203171	TORRENT
TELMISARTAN	TELMISARTAN	80MG	TABLET;ORAL	Prescription	No	AB	203325	ZYDUS PHARMS

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