Application 074140

Type: ANDA
Sponsor: FOSUN PHARMA

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
A074140-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21
A074140-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21
A074140-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074140-001	AB
A074140-002	AB
A074140-003	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	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074140-002	NAPROXEN	375MG	TABLET / ORAL	AB	1993-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074140-003	NAPROXEN	500MG	TABLET / ORAL	AB	1993-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074140-001	NAPROXEN	250MG	TABLET / ORAL	AB	1993-12-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A074140-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074140-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074140-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074140-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074140-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074140-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074140-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074140-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074140-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074140-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074140-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074140-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074140-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074140-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074140-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074140-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074140-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074140-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074140-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074140-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074140-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074140-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074140-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074140-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074140-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074140-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074140-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074140-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074140-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074140-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074140-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074140-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074140-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074140-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074140-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074140-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074140-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074140-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074140-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074140-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Redpharm Drug	52503536-593e-808b-e063-6294a90a737f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140
Naproxen	NAPROXEN	REMEDYREPACK INC.	12202ef3-c65e-45a6-88ed-5d945d8fd41c	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140
Naproxen	NAPROXEN	Northwind Health Company, LLC	0de6d673-fa76-e9c0-e063-6394a90a9ded	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140
Naproxen	NAPROXEN	Northwind Health Company, LLC	fb07a76b-98ce-85dd-e053-6294a90aa6a8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140
Naproxen	NAPROXEN	Granules Pharmaceuticals Inc.	c1cb9bb9-fbae-5e5c-e053-2995a90a0d21	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140 ndc (product): 70010-139 ndc (product): 70010-138 ndc (product): 70010-137
Naproxen	NAPROXEN SODIUM	Granules India Ltd	1f8da545-bcfe-4c22-a9f1-d34108120aa0	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140 ndc (product): 62207-745 ndc (product): 62207-746 ndc (product): 62207-747
Naproxen	NAPROXEN	REMEDYREPACK INC.	e519fa49-5bd9-405c-a7fb-1403edb8976b	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074140 application number: ANDA074140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62207-745	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-745	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-745	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-745	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-745	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-745	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-746	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-746	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-746	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-746	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-746	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-746	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-747	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-747	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-747	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-747	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-747	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
62207-747	Naproxen	Naproxen Sodium	Granules India Ltd	ANDA	Current
70010-137	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-137	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-137	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-137	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-138	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-138	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-138	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-138	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-139	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-139	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-139	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current
70010-139	Naproxen	Naproxen Sodium	Granules Pharmaceuticals Inc.	ANDA	Current