Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208994
Company: PHARMALUCENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNETIUM TC99M MERTIATIDE KIT TECHNETIUM TC-99M MERTIATIDE 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
07/12/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208994Orig1s000ltr.pdf

TECHNETIUM TC99M MERTIATIDE KIT

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TECHNESCAN MAG3 TECHNETIUM TC-99M MERTIATIDE KIT N/A INJECTABLE;INJECTION Prescription Yes AP 019882 CURIUM
TECHNETIUM TC99M MERTIATIDE KIT TECHNETIUM TC-99M MERTIATIDE KIT N/A INJECTABLE;INJECTION Prescription No AP 208994 PHARMALUCENCE

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