Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204356
Company: WISCONSIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/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
12/18/2014 ORIG-1 Approval

Label is not available on this site.

AMMONIA N 13

INJECTABLE;INTRAVENOUS; 3.75mCi-260mCi/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 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 205687 ESSENTIAL ISOTOPES
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 215083 METHODIST
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204515 NCM USA BRONX LLC
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204547 PRECISION NUCLEAR
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204366 SHERTECH LABS LLC
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203543 SOFIE
AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204356 WISCONSIN

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English