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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073449
Company: WATSON LABS

Products on ANDA 073449

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/1993	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
02/25/2022	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
06/11/2012	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/24/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
11/07/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
12/24/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1999	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/15/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-3	Labeling		Label is not available on this site.
08/12/1997	SUPPL-2	Labeling		Label is not available on this site.
08/12/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073449

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
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

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