Details for New Drug Application (NDA): 213536

NDA 213536 describes REZIPRES, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from one supplier. Additional details are available on the REZIPRES profile page.

The generic ingredient in REZIPRES is ephedrine hydrochloride. There are sixty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ephedrine hydrochloride profile page.

Summary for 213536

Tradename:	REZIPRES
Applicant:	Dr Reddys Labs Sa
Ingredient:	ephedrine hydrochloride
Patents:	0

Pharmacology for NDA: 213536

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Increased Norepinephrine Activity

Suppliers and Packaging for NDA: 213536

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REZIPRES	ephedrine hydrochloride	SOLUTION;INTRAVENOUS	213536	NDA	Dr. Reddy's Laboratories Inc	43598-181	43598-181-11	10 mL in 1 VIAL, SINGLE-DOSE (43598-181-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	23.5MG/5ML (4.7MG/ML)
Approval Date:	Jun 14, 2021	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	47MG/ML (47MG/ML)
Approval Date:	Jun 14, 2021	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	47MG/5ML (9.4MG/ML)
Approval Date:	Jun 14, 2021	TE:		RLD:	Yes

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