Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018963
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHOLETEC TECHNETIUM TC-99M MEBROFENIN KIT N/A INJECTABLE;INJECTION Prescription AP 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
01/21/1987 ORIG-1 Approval Type 1 - New Molecular Entity 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
09/10/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/19/2007 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

07/01/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/19/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/24/1993 SUPPL-2 Labeling

Label is not available on this site.

CHOLETEC

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHOLETEC TECHNETIUM TC-99M MEBROFENIN KIT N/A INJECTABLE;INJECTION Prescription Yes AP 018963 BRACCO
TECHNETIUM TC-99M MEBROFENIN TECHNETIUM TC-99M MEBROFENIN KIT N/A INJECTABLE;INJECTION Prescription No AP 078242 PHARMALUCENCE

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