An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074821
Company: SANDOZ

Products on ANDA 074821

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074821

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1997	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
04/18/2012	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
11/01/2007	SUPPL-23	Labeling		Label is not available on this site.
12/06/2002	SUPPL-17	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
06/27/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
06/27/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
06/27/2002	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
04/19/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/23/2001	SUPPL-12	Labeling		Label is not available on this site.
11/06/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/25/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/12/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/14/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/14/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/20/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074821

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE;ORAL	Prescription	No	AB	208358	CADILA
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE;ORAL	Prescription	No	AB	201407	LANNETT CO INC
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE;ORAL	Prescription	No	AB	074821	SANDOZ

Top