Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016847
Company: GE HEALTHCARE

Products on NDA 016847

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOPAQUE 440	CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM	0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016847

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1973	ORIG-1	Approval	Type 2 New Active Ingredient and Type 4 New Combination	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
02/15/1979	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/1978	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/14/1977	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/1977	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/14/1977	SUPPL-4	Labeling		Label is not available on this site.
11/21/1975	SUPPL-3	Labeling		Label is not available on this site.
03/26/1976	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.