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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 200219

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NDA 200219 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 200219

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

Pharmacology for NDA: 200219

Physiological Effect	Increased Uterine Smooth Muscle Contraction or Tone

Medical Subject Heading (MeSH) Categories for 200219

Oxytocics

Suppliers and Packaging for NDA: 200219

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYTOCIN	oxytocin	INJECTABLE;INJECTION	200219	ANDA	West-Ward Pharmaceuticals Corp	0143-9742	0143-9742-25	25 VIAL in 1 CARTON (0143-9742-25) / 10 mL in 1 VIAL (0143-9742-01)
OXYTOCIN	oxytocin	INJECTABLE;INJECTION	200219	ANDA	West-Ward Pharmaceuticals Corp	0143-9743	0143-9743-25	25 VIAL in 1 CARTON (0143-9743-25) / 1 mL in 1 VIAL (0143-9743-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10USP UNITS/ML (10USP UNITS/ML)
Approval Date:	Feb 13, 2013	TE:	AP	RLD:	No

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