Details for New Drug Application (NDA): 208358

NDA 208358 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Norvium Bioscience, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon, Watson Labs, and Zydus Pharms, and is included in twenty-two NDAs. It is available from twenty-nine suppliers. Additional details are available on the TRIAMTERENE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in TRIAMTERENE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for 208358

Tradename:	TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Applicant:	Cadila
Ingredient:	hydrochlorothiazide; triamterene
Patents:	0

Pharmacology for NDA: 208358

Physiological Effect

Decreased Renal K+ Excretion Increased Diuresis

Suppliers and Packaging for NDA: 208358

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	208358	ANDA	St Mary's Medical Park Pharmacy	60760-783	60760-783-90	90 CAPSULE in 1 BOTTLE, PLASTIC (60760-783-90)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	208358	ANDA	NuCare Pharmaceuticals,Inc.	68071-2533	68071-2533-9	90 CAPSULE in 1 BOTTLE (68071-2533-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG;37.5MG
Approval Date:	Feb 11, 2019	TE:	AB	RLD:	No

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