FDA.reportPublic FDA data

Application 203933

Type
ANDA
Sponsor
UNIV TX MD ANDERSON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMMONIA N 13AMMONIA N-13INJECTABLE;INTRAVENOUS30mCi-300mCi/8ML (3.75-37.5mCi/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203933-001AMMONIA N 13AMMONIA N-1330mCi-300mCi/8ML (3.75-37.5mCi/ML)INJECTABLE / INTRAVENOUS2014-06-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A203933-001AMMONIA N 1330mCi-300mCi/8ML (3.75-37.5mCi/ML)INJECTABLE / INTRAVENOUS2014-06-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203933-001AMMONIA N 1330mCi-300mCi/8ML (3.75-37.5mCi/ML)INJECTABLE / INTRAVENOUS2014-06-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203933-001AMMONIA N 1330mCi-300mCi/8ML (3.75-37.5mCi/ML)INJECTABLE / INTRAVENOUS2014-06-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203933-001AMMONIA N 1330mCi-300mCi/8ML (3.75-37.5mCi/ML)INJECTABLE / INTRAVENOUS2014-06-27a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ammonia N 13AMMONIA N-13Biomedical Research Foundation of Northwest Louisianaa4a2bb1a-1ecc-48e4-a87b-60fc583f61ce2026-06-10Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-13Ionetix Corporation61e196ba-3812-4ffd-8032-12b215378fef2026-04-10Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-13Kreitchman PET Center26572b37-0999-4c83-8206-1c088026d4072026-01-27Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-133D Imaging Drug Design and Development LLCfce62c22-a1e2-4193-8de5-e1961d9b94a52026-01-07Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-13Mayo Clinicaf70d0da-1c2d-44e4-b4cd-7cce6636c7b92025-12-26Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-13PETNET Solutions, Inc.b1559f8a-1fc8-4a9e-b4f4-5e2efcb1f12c2025-12-03Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13NH3N13UCSF Radiopharmaceutical Facility1f93d72b-6595-4f5f-8ecc-664a612471e52025-11-14Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
Ammonia N 13AMMONIA N 13University of Wisconsin System730595b1-605c-40a2-8f89-2c3eae98f88a2025-10-14Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
Ammonia N 13AMMONIA N-13SOFIE Co. dba SOFIE85882893-0661-46c2-a5f2-a73f6ea4fb5a2025-04-03Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N 13SOFIE Co. dba SOFIEd24f8595-2231-4f15-ac2b-9148ec4533242025-04-01Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
AMMONIA N-13AMMONIA N-13Precision Nuclear LLCcc430bfd-6940-41ca-bda4-6d29eb4dc1f22024-12-11Warnings, Adverse reactionsName fallback
generic name: AMMONIA N-13
Ammonia N-13AMMONIA N-13The Methodist Hospital Research Institutec79222b1-7dd8-f1fe-e053-2a95a90a36392023-12-19Warnings, Adverse reactionsName fallback
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-13The University of Texas Southwestern Medical Centere901d193-527d-4e39-8727-c152b56fb9e22022-11-17Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
Ammonia N 13AMMONIA N-13Massachusetts General Hospital57947a8c-939e-4468-805c-2f2001041fe42021-11-25Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
generic name: AMMONIA N-13
AMMONIA N-13AMMONIA N-13Brigham and Women's Hospital, Inc., The3c3c98bd-a052-4564-a15f-37dc6d0327072021-11-03Warnings, Adverse reactionsName fallback
generic name: AMMONIA N-13
Ammonia N 13NH3N13Washington University School of Medicine611f4a03-5b6f-420a-925e-adb905bf7b512021-10-29Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
Ammonia N 13NH3N13THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCHc857724f-b172-4844-ad42-6fa4c42b04052019-10-30Warnings, Adverse reactionsName fallback
brand name: Ammonia N 13
Ammonia N-13AMMONIA N-13Cardinal Health 414, LLC4c563174-c7cd-4224-b865-4da2f39c21c02018-07-11Warnings, Adverse reactionsName fallback
generic name: AMMONIA N-13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.