Details for New Drug Application (NDA): 216460

NDA 216460 describes VALSARTAN, which is a drug marketed by Novitium Pharma, Rubicon, Acme Labs, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Torrent, Unichem, Watson Labs Inc, Zydus Lifesciences, Apotex Inc, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from thirty-two suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for 216460

Tradename:	VALSARTAN
Applicant:	Rubicon
Ingredient:	valsartan
Patents:	0

Pharmacology for NDA: 216460

Mechanism of Action

Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 216460

Angiotensin II Type 1 Receptor Blockers

Antihypertensive Agents

Suppliers and Packaging for NDA: 216460

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VALSARTAN	valsartan	SOLUTION;ORAL	216460	ANDA	Advagen Pharma Ltd	72888-184	72888-184-13	473 mL in 1 BOTTLE (72888-184-13)
VALSARTAN	valsartan	SOLUTION;ORAL	216460	ANDA	Advagen Pharma Ltd	72888-184	72888-184-48	120 mL in 1 BOTTLE (72888-184-48)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	4MG/ML
Approval Date:	Jun 5, 2025	TE:	AB	RLD:	No

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