Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018321
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNESCAN TECHNETIUM TC-99M OXIDRONATE KIT N/A INJECTABLE;INJECTION 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
02/18/1981 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
03/31/2017 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018321s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018321Orig1s022ltr.pdf
06/17/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/08/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/14/1994 SUPPL-15 Labeling

Label is not available on this site.

09/30/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/05/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/10/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/28/1989 SUPPL-8 Efficacy-New Patient Population

Label is not available on this site.

02/03/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/29/1996 SUPPL-5 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
03/31/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018321s022lbl.pdf

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