Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020504
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICROZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/27/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2020 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020504Orig1s026ltr.pdf
01/26/2017 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/16/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/15/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020504s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020504s018ltr.pdf
12/20/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/07/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2020 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf
03/15/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020504s018lbl.pdf

MICROZIDE

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 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 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 TEVA BRANDED PHARM

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