Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203155
Company: MCPRF
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 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
09/12/2012 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203155Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203155Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203155Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/16/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/28/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/30/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/30/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/26/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/12/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203155s000lbl.pdf

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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