Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017858
Company: PHARMALUCENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AN-SULFUR COLLOID TECHNETIUM TC-99M SULFUR COLLOID KIT N/A SOLUTION;INJECTION, ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/17/1978 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
12/04/2015 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

09/28/2015 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/22/2015 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/13/2015 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/22/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/04/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/14/2012 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/13/2012 SUPPL-35 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017858Orig1s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/017858Orig1s035MedR.pdf
07/22/2011 SUPPL-34 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017858s034ltr.pdf
09/13/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17858slr024ltr.pdf
08/04/1998 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/25/1995 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1989 SUPPL-20 Labeling

Label is not available on this site.

04/02/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/12/1986 SUPPL-15 Efficacy

Label is not available on this site.

04/29/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/10/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1985 SUPPL-7 Labeling

Label is not available on this site.

01/11/1982 SUPPL-5 Labeling

Label is not available on this site.

06/30/1982 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1982 SUPPL-2 Labeling

Label is not available on this site.

05/11/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/13/2012 SUPPL-35 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017858s035lbl.pdf
07/22/2011 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017858s034lbl.pdf

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