Application 083720

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PROBENECID AND COLCHICINE	COLCHICINE; PROBENECID	TABLET;ORAL	0.5MG;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
A083720-002	PROBENECID AND COLCHICINE	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET / ORAL		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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A083720-002	PROBENECID AND COLCHICINE	0.5MG;500MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083720-002	PROBENECID AND COLCHICINE	0.5MG;500MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083720-002	PROBENECID AND COLCHICINE	0.5MG;500MG	TABLET / ORAL	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Probenecid and Colchicine	PROBENECID AND COLCHICINE	REMEDYREPACK INC.	573e61e5-f5e1-4119-9d8e-d9a961a1baa9	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Probenecid and Colchicine
Probenecid and Colchicine	PROBENECID AND COLCHICINE	Rising Pharma Holdings, Inc.	3d2a3d4f-38a3-4669-ad78-ab1d7aef4ec3	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Probenecid and Colchicine
Probenecid and Colchicine	PROBENECID AND COLCHICINE	Ingenus Pharmaceuticals, LLC	b85d3e27-70ff-4533-b463-410e4fb23813	2023-06-13	Warnings, Adverse reactions	Name fallback brand name: Probenecid and Colchicine
Probenecid and Colchicine	PROBENECID AND COLCHICINE	Actavis Pharma, Inc.	a0567fe6-132b-463b-bc46-9f5a2a2478fb	2016-12-01	Warnings, Adverse reactions	Name fallback brand name: Probenecid and Colchicine

Reported adverse events (FAERS/openFDA)#

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