Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017538
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNESCAN PYP KIT TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A INJECTABLE;INJECTION Prescription AP 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
05/28/1974 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
03/21/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017538s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017538Orig1s019ltr.pdf
11/25/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/26/2007 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

04/08/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/23/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/22/1988 SUPPL-12 Labeling

Label is not available on this site.

01/30/1989 SUPPL-11 Efficacy-New Route Of Administration

Label is not available on this site.

05/21/1984 SUPPL-10 Labeling

Label is not available on this site.

05/07/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1978 SUPPL-8 Labeling

Label is not available on this site.

11/09/1978 SUPPL-7 Labeling

Label is not available on this site.

08/23/1977 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/27/1977 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/11/1977 SUPPL-4 Labeling

Label is not available on this site.

01/13/1976 SUPPL-2 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
03/21/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017538s019lbl.pdf

TECHNESCAN PYP KIT

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIS-PYRO TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A INJECTABLE;INJECTION Prescription No AP 019039 PHARMALUCENCE
TECHNESCAN PYP KIT TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A INJECTABLE;INJECTION Prescription No AP 017538 CURIUM

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