Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205391
Company: AUROBINDO PHARMA LTD
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 Prescription AB 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 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
04/24/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205391Orig1s000ltr.pdf

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;20MG
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;20MG TABLET;ORAL Prescription Yes AB 021532 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 204233 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 205391 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 078827 MYLAN
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 207804 PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 206515 TORRENT
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET;ORAL Prescription No AB 208847 UMEDICA LABS PVT LTD

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 DAIICHI SANKYO
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 LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET;ORAL Prescription No AB 078827 MYLAN
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

TABLET;ORAL; 25MG;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 25MG;40MG TABLET;ORAL Prescription Yes AB 021532 DAIICHI SANKYO
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 204233 ALEMBIC PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 205391 AUROBINDO PHARMA LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 078827 MYLAN
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 207804 PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 206515 TORRENT
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET;ORAL Prescription No AB 208847 UMEDICA LABS PVT LTD

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