Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206489
Company: SOMMER PHARMS II LLC
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
02/06/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

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 206489 SOMMER PHARMS II LLC
TECHNETIUM TC99M MERTIATIDE KIT TECHNETIUM TC-99M MERTIATIDE KIT N/A INJECTABLE;INJECTION Prescription No AP 208994 SUN PHARM INDS INC

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