Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204352
Company: BIOMEDCL RES FDN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIA N 13 AMMONIA N-13 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/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
05/01/2015 ORIG-1 Approval STANDARD

Label is not available on this site.

AMMONIA N 13

INJECTABLE;INTRAVENOUS; 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMMONIA N 13 AMMONIA N-13 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204352 BIOMEDCL RES FDN

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