Details for New Drug Application (NDA): 018261

NDA 018261 describes PITOCIN, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the PITOCIN profile page.

The generic ingredient in PITOCIN 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 018261

Tradename:	PITOCIN
Applicant:	Endo Operations
Ingredient:	oxytocin
Patents:	0

Pharmacology for NDA: 018261

Physiological Effect

Increased Uterine Smooth Muscle Contraction or Tone

Medical Subject Heading (MeSH) Categories for 018261

Oxytocics

Suppliers and Packaging for NDA: 018261

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PITOCIN	oxytocin	INJECTABLE;INJECTION	018261	NDA	Endo USA, Inc.	42023-116	42023-116-73	25 VIAL in 1 CARTON (42023-116-73) / 10 mL in 1 VIAL
PITOCIN	oxytocin	INJECTABLE;INJECTION	018261	NDA	Endo USA, Inc.	42023-116	42023-116-83	25 VIAL in 1 CARTON (42023-116-83) / 1 mL in 1 VIAL

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:	Jul 27, 2007	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500USP UNITS/50ML (10USP UNITS/ML)
Approval Date:	Sep 5, 2012	TE:		RLD:	Yes

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