Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017776
Company: JUBILANT DRAXIMAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PULMOLITE TECHNETIUM TC-99M ALBUMIN AGGREGATED 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
11/16/1976 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
07/30/2002 SUPPL-19 Supplement

Label is not available on this site.

05/24/2001 SUPPL-18 Supplement

Label is not available on this site.

06/15/2000 SUPPL-16 Supplement

Label is not available on this site.

02/07/2000 SUPPL-15 Supplement

Label is not available on this site.

07/13/1999 SUPPL-14 Supplement

Label is not available on this site.

03/24/1998 SUPPL-13 Supplement

Label is not available on this site.

10/01/1997 SUPPL-12 Supplement

Label is not available on this site.

01/25/1995 SUPPL-11 Supplement

Label is not available on this site.

05/02/1989 SUPPL-10 Supplement

Label is not available on this site.

05/19/1989 SUPPL-9 Supplement

Label is not available on this site.

05/03/1985 SUPPL-8 Supplement

Label is not available on this site.

07/31/1992 SUPPL-7 Supplement

Label is not available on this site.

05/31/1983 SUPPL-6 Supplement

Label is not available on this site.

10/22/1985 SUPPL-5 Supplement

Label is not available on this site.

07/24/1980 SUPPL-4 Supplement

Label is not available on this site.

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