Details for New Drug Application (NDA): 210845

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NDA 210845 describes ISOPROTERENOL HYDROCHLORIDE, which is a drug marketed by 3M, Alpharma Us Pharms, Abraxis Pharm, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Baxter Hlthcare, Cipla, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Intl Medication, Micro Labs, Nexus, Norvium Bioscience, Penn Life, Somerset Theraps Llc, Zydus Pharms, Armour Pharm, DEY, and Parke Davis, and is included in twenty-eight NDAs. It is available from twelve suppliers. Additional details are available on the ISOPROTERENOL HYDROCHLORIDE profile page.

The generic ingredient in ISOPROTERENOL HYDROCHLORIDE is isoproterenol hydrochloride. There are seventeen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.

Tradename:	ISOPROTERENOL HYDROCHLORIDE
Applicant:	Micro Labs
Ingredient:	isoproterenol hydrochloride
Patents:	0

Mechanism of Action	Adrenergic beta-Agonists

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	210845	ANDA	Micro Labs Limited	42571-294	42571-294-79	25 CARTON in 1 CARTON (42571-294-79) / 5 AMPULE in 1 CARTON (42571-294-78) / 1 mL in 1 AMPULE
ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	210845	ANDA	Micro Labs Limited	42571-330	42571-330-80	10 AMPULE in 1 CARTON (42571-330-80) / 5 mL in 1 AMPULE

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.2MG/ML
Approval Date:	Feb 16, 2021	TE:	AP	RLD:	No

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