Drugs@FDA: FDA Approved Drug Products

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

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