Details for New Drug Application (NDA): 211290

NDA 211290 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Endo Operations, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, I3 Pharms, and Riconpharma Llc, and is included in thirty-six NDAs. It is available from twenty suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.

Summary for 211290

Tradename:	ISOSORBIDE DINITRATE
Applicant:	Endo Operations
Ingredient:	isosorbide dinitrate
Patents:	0

Pharmacology for NDA: 211290

Physiological Effect

Vasodilation

Medical Subject Heading (MeSH) Categories for 211290

Nitric Oxide Donors

Vasodilator Agents

Suppliers and Packaging for NDA: 211290

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	211290	ANDA	Endo USA, Inc.	49884-556	49884-556-01	100 TABLET in 1 BOTTLE (49884-556-01)
ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	211290	ANDA	Bryant Ranch Prepack	63629-9593	63629-9593-1	100 TABLET in 1 BOTTLE (63629-9593-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Nov 23, 2021	TE:	AB	RLD:	No

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