Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200219
Company: HIKMA FARMACEUTICA

Products on ANDA 200219

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	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 200219

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	PAR STERILE PRODUCTS