Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 018263
Company: PHARMALUCENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICROLITE TECHNETIUM TC-99M ALBUMIN COLLOID KIT N/A 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
03/25/1983 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/1989 SUPPL-10 Supplement

Label is not available on this site.

05/02/1989 SUPPL-9 Supplement

Label is not available on this site.

09/24/1987 SUPPL-8 Supplement

Label is not available on this site.

03/17/1989 SUPPL-7 Supplement

Label is not available on this site.

05/06/1986 SUPPL-5 Supplement

Label is not available on this site.

08/26/1987 SUPPL-4 Supplement

Label is not available on this site.

07/18/1984 SUPPL-2 Supplement

Label is not available on this site.

05/31/1983 SUPPL-1 Supplement

Label is not available on this site.

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