Application 200429

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	TABLET;ORAL	250MG	No	No
002	NAPROXEN	NAPROXEN	TABLET;ORAL	375MG	No	No
003	NAPROXEN	NAPROXEN	TABLET;ORAL	500MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200429-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08
A200429-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08
A200429-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200429-001	AB
A200429-002	AB
A200429-003	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 4 · 123 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	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A200429-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200429-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200429-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200429-001	AB	1	`8072bd15b7f6…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Bryant Ranch Prepack	e0f430fd-4511-41c8-b5e9-894abe4f3c37	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	Aurobindo Pharma Limited	0e5315bc-c02f-4749-be69-b5b528327d58	2025-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429 ndc (product): 65862-522 ndc (product): 65862-521 ndc (product): 65862-520
Naproxen	NAPROXEN	Coupler LLC	3375e139-d9de-8c2d-e063-6394a90a653d	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9ac948-4405-5abf-e053-2995a90af2b5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429 ndc (product): 80425-0051
Naproxen	NAPROXEN	A-S Medication Solutions	f91c1a6b-b256-42e1-9da0-5f1975dec6ce	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	a8b54258-84e7-41e8-9e51-137a3f442e6b	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	50c52976-9e04-4a5e-9f21-aca3ea5c2924	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	d801ba16-e2ec-4bb2-8cff-32388634b35a	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-214	Naproxen	Naproxen	Citron Pharma LLC	ANDA	Current
57237-215	Naproxen	Naproxen	Citron Pharma LLC	ANDA	Current
57237-216	Naproxen	Naproxen	Citron Pharma LLC	ANDA	Current
65862-520	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-520	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-520	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-520	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-521	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-521	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-521	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-521	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-522	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-522	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-522	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
65862-522	Naproxen	Naproxen	Aurobindo Pharma Limited	ANDA	Current
80425-0051	Naprosyn	Naproxen 500mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0051	Naproxen	Naproxen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0051	Naproxen	Naproxen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current