Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201586
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription AB No No
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription AB No No
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription AB No No
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;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
01/08/2014 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201586Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2019 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

09/02/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/02/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

TELMISARTAN AND AMLODIPINE

TABLET;ORAL; EQ 5MG BASE;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 10MG BASE;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 5MG BASE;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 10MG BASE;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 205234 ALEMBIC PHARMS LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 201586 LUPIN LTD
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 202516 MYLAN
TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription No AB 202517 TORRENT
TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET;ORAL Prescription Yes AB 022401 BOEHRINGER INGELHEIM

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