Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020091
Company: ALLIANCE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMAGENT PERFLUBRON 100% LIQUID;ORAL 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
08/13/1993 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
08/27/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1993 SUPPL-1 Labeling

Label is not available on this site.

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