Application 084211

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PROBENECID	PROBENECID	TABLET;ORAL	500MG	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
A084211-002	PROBENECID	PROBENECID	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 · 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	A084211-002	PROBENECID	500MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084211-002	PROBENECID	500MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084211-002	PROBENECID	500MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084211-002	PROBENECID	500MG	TABLET / ORAL	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A084211-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084211-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084211-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084211-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084211-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084211-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084211-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084211-002	AB	1	`ea99ee380514…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0156	Probenecid	probenecid	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-991	Probenecid	probenecid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-991	Probenecid	probenecid	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68151-1993	Probenecid	probenecid	Carilion Materials Management	ANDA	Current