Application 204366

Type: ANDA
Sponsor: SHERTECH LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMMONIA N 13	AMMONIA N-13	INJECTABLE;INTRAVENOUS	3.75-260mCi/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204366-001	AMMONIA N 13	AMMONIA N-13	3.75mCi-260mCi/ML	INJECTABLE / INTRAVENOUS			2014-09-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A204366-001	AMMONIA N 13	3.75mCi-260mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-09-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204366-001	AMMONIA N 13	3.75mCi-260mCi/ML	INJECTABLE / INTRAVENOUS	AP	2014-09-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204366-001	AMMONIA N 13	3.75mCi-260mCi/ML	INJECTABLE / INTRAVENOUS		2014-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204366-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204366-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204366-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204366-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204366-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204366-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204366-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204366-001	AP	1	`8869cabd3fbd…`
2023-12-20 04:57 UTC	2023-12	A204366-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204366-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204366-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204366-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204366-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204366-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204366-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204366-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204366-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204366-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204366-001	AP	1	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ammonia N 13	AMMONIA N-13	Biomedical Research Foundation of Northwest Louisiana	a4a2bb1a-1ecc-48e4-a87b-60fc583f61ce	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	Ionetix Corporation	61e196ba-3812-4ffd-8032-12b215378fef	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	Kreitchman PET Center	26572b37-0999-4c83-8206-1c088026d407	2026-01-27	Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	3D Imaging Drug Design and Development LLC	fce62c22-a1e2-4193-8de5-e1961d9b94a5	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	Mayo Clinic	af70d0da-1c2d-44e4-b4cd-7cce6636c7b9	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	PETNET Solutions, Inc.	b1559f8a-1fc8-4a9e-b4f4-5e2efcb1f12c	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	NH3N13	UCSF Radiopharmaceutical Facility	1f93d72b-6595-4f5f-8ecc-664a612471e5	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13
Ammonia N 13	AMMONIA N 13	University of Wisconsin System	730595b1-605c-40a2-8f89-2c3eae98f88a	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13
Ammonia N 13	AMMONIA N-13	SOFIE Co. dba SOFIE	85882893-0661-46c2-a5f2-a73f6ea4fb5a	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N 13	SOFIE Co. dba SOFIE	d24f8595-2231-4f15-ac2b-9148ec453324	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13
AMMONIA N-13	AMMONIA N-13	Precision Nuclear LLC	cc430bfd-6940-41ca-bda4-6d29eb4dc1f2	2024-12-11	Warnings, Adverse reactions	Name fallback generic name: AMMONIA N-13
Ammonia N-13	AMMONIA N-13	The Methodist Hospital Research Institute	c79222b1-7dd8-f1fe-e053-2a95a90a3639	2023-12-19	Warnings, Adverse reactions	Name fallback generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	The University of Texas Southwestern Medical Center	e901d193-527d-4e39-8727-c152b56fb9e2	2022-11-17	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
Ammonia N 13	AMMONIA N-13	Massachusetts General Hospital	57947a8c-939e-4468-805c-2f2001041fe4	2021-11-25	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13 generic name: AMMONIA N-13
AMMONIA N-13	AMMONIA N-13	Brigham and Women's Hospital, Inc., The	3c3c98bd-a052-4564-a15f-37dc6d032707	2021-11-03	Warnings, Adverse reactions	Name fallback generic name: AMMONIA N-13
Ammonia N 13	NH3N13	Washington University School of Medicine	611f4a03-5b6f-420a-925e-adb905bf7b51	2021-10-29	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13
Ammonia N 13	NH3N13	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	c857724f-b172-4844-ad42-6fa4c42b0405	2019-10-30	Warnings, Adverse reactions	Name fallback brand name: Ammonia N 13
Ammonia N-13	AMMONIA N-13	Cardinal Health 414, LLC	4c563174-c7cd-4224-b865-4da2f39c21c0	2018-07-11	Warnings, Adverse reactions	Name fallback generic name: AMMONIA N-13

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16129-003	Ammonia	AMMONIA N-13	Shertech Laboratories, LLC	ANDA	Current
16129-003	Ammonia	AMMONIA N-13	Shertech Laboratories, LLC	ANDA	Current
16129-003	Ammonia	AMMONIA N-13	Shertech Laboratories, LLC	ANDA	Current
16129-003	Ammonia	AMMONIA N-13	Shertech Laboratories, LLC	ANDA	Current
16129-003	Ammonia	AMMONIA N-13	Shertech Laboratories, LLC	ANDA	Current