Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017714
Company: JUBILANT DRAXIMAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AN-DTPA TECHNETIUM TC-99M PENTETATE 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
11/16/1976 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
12/12/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2002 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17714s21ltr.pdf
05/27/1997 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1993 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1986 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/27/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/29/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/23/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1983 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/07/1979 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/07/1979 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/07/1979 SUPPL-1 Labeling

Label is not available on this site.

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