Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017982
Company: GE HEALTHCARE

Products on NDA 017982

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMIPAQUE	METRIZAMIDE	3.75GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
AMIPAQUE	METRIZAMIDE	6.75GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
AMIPAQUE	METRIZAMIDE	2.5GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
AMIPAQUE	METRIZAMIDE	13.5GM/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017982

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/1978	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/1989	SUPPL-24	Labeling		Label is not available on this site.
11/20/1986	SUPPL-23	Labeling		Label is not available on this site.
08/04/1987	SUPPL-22	Labeling		Label is not available on this site.
05/23/1988	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/12/1983	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/10/1983	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/12/1983	SUPPL-17	Efficacy		Label is not available on this site.
07/09/1982	SUPPL-11	Labeling		Label is not available on this site.
10/02/1981	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/18/1981	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/17/1983	SUPPL-6	Efficacy		Label is not available on this site.
02/29/1980	SUPPL-5	Labeling		Label is not available on this site.
02/29/1980	SUPPL-2	Labeling		Label is not available on this site.