Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091370
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription AB No No
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription AB No No
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG 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
10/12/2016 ORIG-2 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091370Orig1s000ltr.pdf
10/15/2012 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
08/29/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

IRBESARTAN AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription Yes AB 020758 SANOFI AVENTIS US
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 091370 ALEMBIC PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 201505 APOTEX INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 203036 ATLAS PHARMS LLC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 203630 AUROBINDO PHARMA LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 203500 DR REDDYS LABS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 207896 HISUN PHARM HANGZHOU
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 201524 LUPIN LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 202414 MACLEODS PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 077969 MYLAN PHARMS INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 203072 PRINSTON INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 077446 SANDOZ
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 077369 TEVA
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 207018 UNICHEM LABS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 090351 WEST-WARD PHARMS INT

TABLET;ORAL; 12.5MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVALIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription Yes AB 020758 SANOFI AVENTIS US
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 091370 ALEMBIC PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 201505 APOTEX INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 203036 ATLAS PHARMS LLC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 203630 AUROBINDO PHARMA LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 203500 DR REDDYS LABS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 207896 HISUN PHARM HANGZHOU
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 201524 LUPIN LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 202414 MACLEODS PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 077969 MYLAN PHARMS INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 203072 PRINSTON INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 077446 SANDOZ
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 077369 TEVA
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 207018 UNICHEM LABS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 090351 WEST-WARD PHARMS INT

TABLET;ORAL; 25MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET;ORAL Prescription No AB 091370 ALEMBIC PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET;ORAL Prescription No AB 203036 ATLAS PHARMS LLC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET;ORAL Prescription No AB 203630 AUROBINDO PHARMA LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET;ORAL Prescription No AB 077969 MYLAN PHARMS INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET;ORAL Prescription No AB 090351 WEST-WARD PHARMS INT

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