Application 084442

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	PROBENECID	PROBENECID	TABLET;ORAL	500MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A084442-004	PROBENECID	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A084442-004	AB

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084442-004	PROBENECID	500MG	TABLET / ORAL		RS	1983-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084442-004	PROBENECID	500MG	TABLET / ORAL		RS	1983-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084442-004	PROBENECID	500MG	TABLET / ORAL		RS	1983-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084442-004	PROBENECID	500MG	TABLET / ORAL		RS	1983-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084442-004	PROBENECID	500MG	TABLET / ORAL		RS	1983-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084442-004	PROBENECID	500MG	TABLET / ORAL		RS	1983-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB		1983-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB		1983-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084442-004	PROBENECID	500MG	TABLET / ORAL	AB	RS	1983-03-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084442-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084442-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084442-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084442-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084442-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084442-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084442-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084442-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084442-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084442-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084442-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084442-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084442-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084442-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084442-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084442-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084442-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A084442-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084442-004	AB	1	`782e0a99824c…`
2019-09-15 20:21 UTC	2019-09	A084442-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084442-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084442-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084442-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084442-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084442-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084442-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084442-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084442-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084442-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084442-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084442-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084442-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084442-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084442-004	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084442-004	AB	1	`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
Probenecid	PROBENECID	Actavis Pharma, Inc.	ae126418-5474-4fbe-b83c-bde8b2b4ae6e	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084442 application number: ANDA084442 ndc (product): 0591-5347

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
0591-5347	Probenecid	Probenecid	Actavis Pharma, Inc.	ANDA	Current
0591-5347	Probenecid	Probenecid	Actavis Pharma, Inc.	ANDA	Current
11819-282	Probenecid	Probenecid	HHS/Program Support Center/Supply Service Center	ANDA	Current
63629-8213	Probenecid	Probenecid	Bryant Ranch Prepack	ANDA	Current
69367-154	Probenecid	Probenecid	Westminster Pharmaceuticals, LLC	ANDA	Current