Application 083740

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROBENECID	PROBENECID	TABLET;ORAL	500MG	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
A083740-001	PROBENECID	PROBENECID	500MG	TABLET / ORAL			1984-05-09

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	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A083740-001	PROBENECID	500MG	TABLET / ORAL	1984-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083740-001	PROBENECID	500MG	TABLET / ORAL	1984-05-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083740-001	PROBENECID	500MG	TABLET / ORAL	1984-05-09	`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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Probenecid	PROBENECID	REMEDYREPACK INC.	65b4888c-d49a-433f-9bfd-17880ae40069	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID
Probenecid	PROBENECID	Rising Pharma Holdings, Inc.	f2375d90-4132-4fb6-aee7-c4f9d11e98d5	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID
Probenecid	PROBENECID	Marlex Pharmaceuticals Inc	5d552de5-2d18-4464-bcaf-0311fa3f080d	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID
Probenecid	PROBENECID	Bryant Ranch Prepack	a4f4b3e1-44a9-4b3a-9f7f-f9749ed451ca	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID
Probenecid	PROBENECID	Actavis Pharma, Inc.	ae126418-5474-4fbe-b83c-bde8b2b4ae6e	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID
Probenecid	PROBENECID	Bryant Ranch Prepack	6aec72b5-a9f4-45a3-82a6-7d3de64ba5e5	2024-01-26	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID
Probenecid	PROBENECID	Lannett Company, Inc.	ab497fd8-00c3-4364-b003-b39d21fbdf38	2021-01-05	Warnings, Adverse reactions	Name fallback brand name: Probenecid generic name: PROBENECID

Reported adverse events (FAERS/openFDA)#

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