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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200532
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Discontinued None No No
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription AB No No
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Discontinued None 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
04/24/2017 ORIG-1 Approval Not Applicable

Label is not available on this site.

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENICAR HCT HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription Yes AB 021532 COSETTE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 209281 ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 204233 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 205391 AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 207804 PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 200532 TEVA PHARMS USA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 206515 TORRENT
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 208847 UMEDICA LABS PVT LTD
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