Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019185
Company: ABBOTT

Products on NDA 019185

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%	OXYTOCIN	2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%	OXYTOCIN	1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OXYTOCIN 20 USP UNITS IN DEXTROSE 5%	OXYTOCIN	2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
OXYTOCIN 5 USP UNITS IN DEXTROSE 5%	OXYTOCIN	1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019185

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/1985	ORIG-1	Approval	Type 3 - New Dosage Form	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
11/13/1986	SUPPL-4	Labeling		Label is not available on this site.
07/01/1985	SUPPL-1	Labeling		Label is not available on this site.