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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 091676

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NDA 091676 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 091676

Tradename:	OXYTOCIN
Applicant:	Sagent Pharms Inc
Ingredient:	oxytocin
Patents:	0

Medical Subject Heading (MeSH) Categories for 091676

Oxytocics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10USP UNITS/ML (10USP UNITS/ML)
Approval Date:	Jul 13, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100USP UNITS/10ML (10USP UNITS/ML)
Approval Date:	Jul 13, 2018	TE:	AP	RLD:	No

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