Details for New Drug Application (NDA): 018248

NDA 018248 describes OXYTOCIN, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Sagent Pharms Inc, and Abbott, and is included in six NDAs. It is available from five suppliers. Additional details are available on the OXYTOCIN profile page.

The generic ingredient in OXYTOCIN is oxytocin. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

Summary for 018248

Tradename:	OXYTOCIN
Applicant:	Fresenius Kabi Usa
Ingredient:	oxytocin
Patents:	0

Pharmacology for NDA: 018248

Physiological Effect

Increased Uterine Smooth Muscle Contraction or Tone

Medical Subject Heading (MeSH) Categories for 018248

Oxytocics

Suppliers and Packaging for NDA: 018248

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYTOCIN	oxytocin	INJECTABLE;INJECTION	018248	NDA	Cardinal Health 107, LLC	55154-9584	55154-9584-5	5 VIAL in 1 BAG (55154-9584-5) / 1 mL in 1 VIAL
OXYTOCIN	oxytocin	INJECTABLE;INJECTION	018248	NDA	Fresenius Kabi USA, LLC	63323-012	63323-012-07	25 VIAL in 1 TRAY (63323-012-07) / 1 mL in 1 VIAL (63323-012-17)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10USP UNITS/ML (10USP UNITS/ML)
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100USP UNITS/10ML (10USP UNITS/ML)
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	300USP UNITS/30ML (10USP UNITS/ML)
Approval Date:	Jul 27, 2007	TE:		RLD:	Yes

Complete Access Available with Subscription