Application 075845

Type: ANDA
Sponsor: SANDOZ

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
A075845-001	OXAPROZIN	OXAPROZIN	600MG	TABLET / ORAL	AB		2001-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075845-001	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	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075845-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`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	A075845-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075845-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075845-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075845-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075845-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075845-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075845-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075845-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075845-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075845-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075845-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075845-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075845-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075845-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075845-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075845-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075845-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075845-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075845-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075845-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075845-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075845-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075845-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075845-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075845-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075845-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075845-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075845-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075845-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075845-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075845-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075845-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075845-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075845-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075845-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075845-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075845-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075845-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075845-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075845-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaprozin	OXAPROZIN	ST MARY'S MEDICAL PARK PHARMACY	e881dca6-004e-1c3e-e053-2a95a90a02ab	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	SOLA Pharmaceuticals, LLC	450f5941-7f10-42fe-e063-6394a90a4803	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	Proficient Rx LP	e3fbea8c-bc0d-4dcd-a14e-a4575dceeea6	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
COXANTO	OXAPROZIN	SOLA Pharmaceuticals, LLC	918127f0-9f2a-4edf-a2f7-07c01aa52bb5	2025-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	Dr. Reddy's Laboratories Limited	da457b34-ca08-60df-045b-1ae80d2f7e71	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	Amneal Pharmaceuticals NY LLC	d9b0ca6c-4c53-4f6e-918b-02a8c472a194	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	Direct_Rx	284ce161-0a4a-8999-e063-6394a90aa60a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
OXAPROZIN	OXAPROZIN	Chartwell RX, LLC.	db349233-9f09-471c-aeee-f91338d2ffe9	2024-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXAPROZIN generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	Bryant Ranch Prepack	dcb85e40-3427-4e56-910d-c1b07bb5c0fa	2024-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN
Oxaprozin	OXAPROZIN	Bryant Ranch Prepack	c157016e-0777-4ad7-89b8-487c47bb74cb	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxaprozin generic name: OXAPROZIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0141	Oxaprozin	Oxaprozin	Eon Labs, Inc.	ANDA	Current
0185-0141	Oxaprozin	Oxaprozin	Eon Labs, Inc.	ANDA	Current
0185-0141	Oxaprozin	Oxaprozin	Eon Labs, Inc.	ANDA	Current
0185-0141	Oxaprozin	Oxaprozin	Eon Labs, Inc.	ANDA	Current
60760-203	Oxaprozin	Oxaprozin	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-673	OXAPROZIN	OXAPROZIN	DIRECT RX	ANDA	Current
63629-8724	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
63629-8724	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
66336-722	Oxaprozin	Oxaprozin	Dispensing Solutions, Inc.	ANDA	Current
68151-0523	Oxaprozin	Oxaprozin	Carilion Materials Management	ANDA	Current
71335-0902	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
71335-0902	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current
71335-0902	Oxaprozin	Oxaprozin	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8807	ORIG	2001-01-31