Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018243
Company: HIKMA

Products on NDA 018243

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
OXYTOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018243

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1980	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/09/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/10/2007	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/22/1995	SUPPL-12	Labeling		Label is not available on this site.
12/23/1993	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
09/16/1993	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/1990	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
08/02/1988	SUPPL-8	Labeling		Label is not available on this site.
07/14/1987	SUPPL-7	Labeling		Label is not available on this site.
09/24/1987	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/28/1986	SUPPL-5	Labeling		Label is not available on this site.
01/31/1984	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/01/1983	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/1984	SUPPL-2	Labeling		Label is not available on this site.
08/14/1980	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 018243

OXYTOCIN

INJECTABLE;INJECTION; 10USP UNITS/ML (10USP UNITS/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	018248	FRESENIUS KABI USA
OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	018243	HIKMA
OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	No	AP	200219	HIKMA FARMACEUTICA
OXYTOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091676	SAGENT PHARMS INC
PITOCIN	OXYTOCIN	10USP UNITS/ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	018261	PH HEALTH

INJECTABLE;INJECTION; 100USP UNITS/10ML (10USP UNITS/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYTOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	018248	FRESENIUS KABI USA
OXYTOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	018243	HIKMA
OXYTOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	No	AP	091676	SAGENT PHARMS INC
PITOCIN	OXYTOCIN	100USP UNITS/10ML (10USP UNITS/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	018261	PH HEALTH