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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208360
Company: ZYDUS PHARMS

Products on ANDA 208360

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	AB	No	No
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208360

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2018	ORIG-1	Approval		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
12/10/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208360

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG;37.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAXZIDE-25	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	Yes	AB	019129	AUROBINDO PHARMA USA
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	No	AB	071251	APOTEX INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	No	AB	216211	RUBICON RESEARCH
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	No	AB	073281	SANDOZ
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	No	AB	073449	WATSON LABS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	TABLET;ORAL	Prescription	No	AB	208360	ZYDUS PHARMS

TABLET;ORAL; 50MG;75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAXZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	Yes	AB	019129	AUROBINDO PHARMA USA
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	No	AB	071251	APOTEX INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	No	AB	072011	CHARTWELL RX
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	No	AB	216211	RUBICON RESEARCH
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	No	AB	071851	WATSON LABS
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	50MG;75MG	TABLET;ORAL	Prescription	No	AB	208360	ZYDUS PHARMS

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