Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078391
Company: JUBILANT CADISTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;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
02/11/2008 ORIG-1 Approval

Label is not available on this site.

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 200645 ALEMBIC PHARMS LTD
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 078164 AUROBINDO PHARMA
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 079237 IPCA LABS LTD
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 077005 IVAX SUB TEVA PHARMS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 078391 JUBILANT CADISTA
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 075640 MYLAN
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 075907 PRINSTON INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 203561 SCIEGEN PHARMS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 090651 SUN PHARM INDS INC
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription No AB 090510 UNICHEM
MICROZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription Yes AB 020504 ALLERGAN

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