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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020504
Company: TEVA BRANDED PHARM

Products on NDA 020504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MICROZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020504

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.

Labels for NDA 020504

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

Therapeutic Equivalents for NDA 020504

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	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	090510	UNICHEM
MICROZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE;ORAL	Prescription	Yes	AB	020504	TEVA BRANDED PHARM

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