Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202491
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG 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
11/03/2016 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
12/10/2019 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; EQ 5MG BASE;12.5MG;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription No AB 202491 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 5MG BASE;12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 202491 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 5MG BASE;25MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 202491 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 10MG BASE;12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 202491 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

TABLET;ORAL; EQ 10MG BASE;25MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 206137 PAR PHARM INC
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 202491 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription No AB 203580 TORRENT
TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET;ORAL Prescription Yes AB 200175 DAIICHI SANKYO

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