Application 017279

Type: NDA
Sponsor: ISOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLOFIL-125	IOTHALAMATE SODIUM I-125	INJECTABLE;INJECTION	250-300uCi/ML	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017279-001	GLOFIL-125	IOTHALAMATE SODIUM I-125	250-300uCi/ML	INJECTABLE / INJECTION		Approved before 1982

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017279-001	GLOFIL-125	250-300uCi/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017279-001	GLOFIL-125	250-300uCi/ML	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017279-001	GLOFIL-125	250-300uCi/ML	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017279-001	GLOFIL-125	250-300uCi/ML	INJECTABLE / INJECTION	Approved before 1982	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glofil-125	SODIUM IOTHALAMATE I-125 INJECTION	Iso-Tex Diagnostics, Inc.	7f250086-2837-484b-9674-e09856b34cb0	2019-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017279 application number: NDA017279 ndc (product): 50914-7729

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50914-7729	Glofil-125	Sodium Iothalamate I-125 injection	Iso-Tex Diagnostics, Inc.	NDA	Current
50914-7729	Glofil-125	Sodium Iothalamate I-125 injection	Iso-Tex Diagnostics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13104	SUPPL	2002-01-22