Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022119
Company: FEINSTEIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/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
08/23/2007 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022119s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/22119s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022119s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022119s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022119Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022119s001lbl.pdf

AMMONIA N 13

INJECTABLE;INTRAVENOUS; 30mCi-300mCi/8ML (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 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203779 3D IMAGING DRUG
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203783 BRIGHAM WOMENS HOSP
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203700 CARDINAL HEALTH 414
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 022119 FEINSTEIN
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207025 GEN HOSP
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204465 GLOBAL ISOTOPES LLC
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204514 JOHNS HOPKINS UNIV
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203938 KREITCHMAN PET CTR
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203321 MCPRF
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204457 MIDWEST MEDCL
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204535 MIPS CRF
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204455 SPECTRON MRC LLC
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203812 UCLA BIOMEDICAL
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204496 UCSF RODIOPHARM
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 203933 UNIV TX MD ANDERSON
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204506 WA UNIV SCH MED

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