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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018243

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NDA 018243 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 four 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. Five suppliers are listed for this compound. Additional details are available on the oxytocin profile page.

Summary for 018243

Tradename:	OXYTOCIN
Applicant:	Hikma
Ingredient:	oxytocin
Patents:	0

Medical Subject Heading (MeSH) Categories for 018243

Oxytocics

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:	Jan 10, 2007	TE:	AP	RLD:	Yes

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