Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017684
Company: PHARMALUCENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYROLITE TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES 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
11/19/1976 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/07/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/17/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/13/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1989 SUPPL-14 Labeling

Label is not available on this site.

05/02/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/10/1986 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

11/17/1983 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1982 SUPPL-6 Labeling

Label is not available on this site.

08/11/1980 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1983 SUPPL-1 Efficacy

Label is not available on this site.

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