Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208605
Company: CADILA PHARMS LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208605Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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 PHARMS LTD
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 204415 AMNEAL PHARMS
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 206511 AUROBINDO PHARMA LTD
TELMISARTAN TELMISARTAN 20MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD
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 204164 JUBILANT GENERICS
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 INC
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 PHARMS LTD
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 204415 AMNEAL PHARMS
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 206511 AUROBINDO PHARMA LTD
TELMISARTAN TELMISARTAN 40MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD
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 204164 JUBILANT GENERICS
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 INC
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
MICARDIS TELMISARTAN 80MG TABLET;ORAL Prescription Yes AB 020850 BOEHRINGER INGELHEIM
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 202130 ALEMBIC PHARMS LTD
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 204415 AMNEAL PHARMS
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 206511 AUROBINDO PHARMA LTD
TELMISARTAN TELMISARTAN 80MG TABLET;ORAL Prescription No AB 208605 CADILA PHARMS LTD
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 204164 JUBILANT GENERICS
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 INC
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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