Application 208633

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXAPROZIN	OXAPROZIN	TABLET;ORAL	600MG	No	No

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
A208633-001	OXAPROZIN	OXAPROZIN	600MG	TABLET / ORAL	AB		2017-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208633-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208633-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208633-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208633-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208633-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208633-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208633-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208633-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208633-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208633-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208633-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208633-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208633-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208633-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208633-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208633-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208633-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208633-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208633-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208633-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208633-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208633-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208633-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208633-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208633-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208633-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208633-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208633-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208633-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208633-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208633-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208633-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208633-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208633-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208633-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208633-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208633-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208633-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208633-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208633-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208633-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaprozin	OXAPROZIN	Amneal Pharmaceuticals NY LLC	d9b0ca6c-4c53-4f6e-918b-02a8c472a194	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208633 application number: ANDA208633 ndc (product): 69238-1120
Oxaprozin	OXAPROZIN	Bryant Ranch Prepack	c157016e-0777-4ad7-89b8-487c47bb74cb	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208633 application number: ANDA208633 ndc (product): 71335-0617

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60760-092	Oxaprozin	Oxaprozin	St Mary's Medical Park Pharmacy	ANDA	Current
69238-1120	Oxaprozin	Oxaprozin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1120	Oxaprozin	Oxaprozin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1120	Oxaprozin	Oxaprozin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1120	Oxaprozin	Oxaprozin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1120	Oxaprozin	Oxaprozin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1120	Oxaprozin	Oxaprozin	Amneal Pharmaceuticals NY LLC	ANDA	Current
70332-311	Oxaprozin	Oxaprozin	California Pharmaceutical LLC	ANDA	Current
71335-0617	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
71335-0617	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
71335-0617	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
72189-077	OXAPROZIN	OXAPROZIN	DIRECT RX	ANDA	Current