Home Applications 215083 Application 215083
Type ANDA
Sponsor METHODIST Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 3.75mCi-260mCi/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215083-001 AMMONIA N 13 AMMONIA N-13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215083-001 AP
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215083-001 AMMONIA N 13 3.75mCi-260mCi/ML INJECTABLE / INTRAVENOUS AP 2021-07-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69864-002 Ammonia N-13 Ammonia N-13 The Methodist Hospital Research Institute ANDA Current