Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206319
Company: DECATUR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHOLINE C-11 CHOLINE C-11 4-33.1mCi/ML INJECTABLE;INTRAVENOUS 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
11/13/2015 ORIG-1 Approval 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
03/26/2018 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/22/2016 SUPPL-3 Labeling

Label is not available on this site.

03/26/2018 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CHOLINE C-11

INJECTABLE;INTRAVENOUS; 4-33.1mCi/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHOLINE C-11 CHOLINE C-11 4-33.1mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 206319 DECATUR
CHOLINE C-11 CHOLINE C-11 4-33.1mCi/ML INJECTABLE;INTRAVENOUS Prescription Yes AP 203155 MCPRF
CHOLINE C-11 CHOLINE C-11 4-33.1mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 208444 UCSF RODIOPHARM
CHOLINE C-11 CHOLINE C-11 4-33.1mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 208413 WA UNIV SCH MED

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