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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077453

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NDA 077453 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 077453

Tradename:	OXYTOCIN
Applicant:	Dr Reddys
Ingredient:	oxytocin
Patents:	0

Medical Subject Heading (MeSH) Categories for 077453

Oxytocics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10USP UNITS/ML (10USP UNITS/ML)
Approval Date:	Jan 24, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100USP UNITS/10ML (10USP UNITS/ML)
Approval Date:	Jan 24, 2008	TE:		RLD:	No

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