Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018467
Company: PHARMALUCENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPATOLITE TECHNETIUM TC-99M DISOFENIN 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
03/16/1982 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
10/30/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/25/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/16/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/15/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/07/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/05/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/29/1993 SUPPL-14 Efficacy-New Indication Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm
12/29/1993 SUPPL-13 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018467-S13&S14_Hepatolite_toc.cfm
05/02/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-10 Labeling

Label is not available on this site.

05/19/1989 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

05/19/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/28/1986 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1983 SUPPL-2 Labeling

Label is not available on this site.

04/26/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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