Application 021920

Type: NDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM	NAPROXEN SODIUM	CAPSULE;ORAL	EQ 200MG BASE	Yes	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
N021920-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2006-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23
N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23
N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24
N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24
N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24
N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24
N021920-001	9693978	2026-03-03		Drug product	2017-11-13
N021920-001	9693979	2026-03-03		Drug product	2017-11-13

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021920-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2006-02-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 313 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10022344	2026-03-03	U-1731	Drug product	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10022344	2026-03-03	U-1732	Drug product	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10028925	2026-03-03	U-1731	Drug product	2018-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	10028925	2026-03-03	U-1732	Drug product	2018-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	11090280	2026-03-03	U-1731	Drug product	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	11090280	2026-03-03	U-1732	Drug product	2021-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	9693978	2026-03-03		Drug product	2017-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021920-001	9693979	2026-03-03		Drug product	2017-11-13	`b8a1b40f171c…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	9343c79f-9994-4599-bcfe-0a93e49d726e	2026-05-12	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Amazon.com Services LLC	04a298dc-c525-8198-e063-6294a90a6f96	2026-04-27	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
naproxen sodium	NAPROXEN SODIUM	Bionpharma Inc.	ba4f927a-4bbe-0d87-e053-2995a90a8c20	2026-04-20	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	MEIJER DISTRIBUTION INC	89f82399-9f71-49dd-8710-b60f346c576c	2025-12-12	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 41250-225
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36bf8594-9303-c816-e063-6294a90af705	2025-12-08	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	1266393e-b55e-4e34-9710-0b87209f4158	2025-12-04	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 0280-6080
Aleve Easy Open Arthritis Cap	NAPROXEN SODIUM	Bayer HealthCare LLC.	3b5442c6-c6e1-4df3-8cec-40bbb4ec469f	2025-12-04	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 0280-6091
Naproxen Sodium	NAPROXEN SODIUM	Albertsons Companies	f9df7495-9da7-8838-e053-6294a90a6fda	2024-09-30	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	AMERISOURCE BERGEN	16b3bbee-4881-b439-e063-6394a90a7c8f	2024-04-22	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Bionpharma Inc.	3e10256f-0a5f-49e4-9518-a72b10490f89	2023-12-27	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	VALU MERCHANDISERS COMPANY	fed305f1-e32d-e1ff-e053-6294a90a273d	2023-10-03	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	a359c47e-e2b4-5560-e053-2a95a90a2844	2023-03-03	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 11822-0788
Naproxen Sodium	NAPROXEN SODIUM	KROGER COMPANY	7487e685-ea64-43a2-9a4e-f5278840be04	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 30142-285
Naproxen Sodium	NAPROXEN SODIUM	Wal-Mart Stores, Inc.	073ecef7-f5b1-4ee0-98bc-82972e3d84f9	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	a13bd208-f29f-1cbc-e053-2995a90a08ba	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 0363-0102
Naproxen Sodium	NAPROXEN SODIUM	HEB	df8ea301-c48b-4da4-9e8e-5c69cac6cba7	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 37808-049
Naproxen Sodium	NAPROXEN SODIUM	TOP CARE (Topco Associates LLC)	c62b7fa0-5ae9-276c-e053-2995a90ade25	2022-12-29	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 36800-204
Naproxen Sodium	NAPROXEN SODIUM	CHAIN DRUG MARKETING ASSOCIATION INC.	c482db41-b115-c24f-e053-2a95a90a2947	2022-12-21	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920
Naproxen Sodium	NAPROXEN SODIUM	WALGREEN COMPANY	462a7e41-b899-4e08-8113-b48ece0ad8d8	2022-03-17	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920 ndc (product): 0363-0177
Naproxen Sodium	NAPROXEN SODIUM	DISCOUNT DRUG MART, INC.	b00c0e86-4c0b-45bf-948f-824ea0f09e39	2022-03-16	Warnings	Exact identifier application applno (NDA): 021920 application number: NDA021920

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 145 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6080	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6091	Aleve	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0363-0102	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0102	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0102	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0102	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0174	Naproxen Sodium	Naproxen Sodium	Walgreens	NDA	Current
0363-0174	Naproxen Sodium	Naproxen Sodium	Walgreens	NDA	Current
0363-0177	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0177	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0177	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0177	Naproxen Sodium	Naproxen Sodium	WALGREEN COMPANY	NDA	Current
0363-0975	Naproxen Sodium	Naproxen Sodium	Walgreens	NDA	Current
0363-0975	Naproxen Sodium	Naproxen Sodium	Walgreens	NDA	Current
11673-175	Naproxen Sodium	Naproxen Sodium	TARGET Corporation	NDA	Current
11673-175	Naproxen Sodium	Naproxen Sodium	TARGET Corporation	NDA	Current
11673-175	Naproxen Sodium	Naproxen Sodium	TARGET Corporation	NDA	Current
11673-742	Up and Up Naproxen Sodium	Naproxen sodium	Target Corporation	NDA	Current
11673-742	Up and Up Naproxen Sodium	Naproxen sodium	Target Corporation	NDA	Current
11822-0788	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	NDA	Current
11822-0788	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	NDA	Current
11822-0788	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	NDA	Current
11822-0788	Naproxen Sodium	Naproxen Sodium	Rite Aid Corporation	NDA	Current
21130-174	Naproxen Sodium	Naproxen Sodium	Safeway, Inc.	NDA	Current
21130-174	Naproxen Sodium	Naproxen Sodium	Safeway, Inc.	NDA	Current
21130-174	Naproxen Sodium	Naproxen Sodium	Safeway, Inc.	NDA	Current
30142-174	Naproxen Sodium	Naproxen Sodium	The Kroger Co.	NDA	Current
30142-174	Naproxen Sodium	Naproxen Sodium	The Kroger Co.	NDA	Current
30142-174	Naproxen Sodium	Naproxen Sodium	The Kroger Co.	NDA	Current
30142-285	Naproxen Sodium	Naproxen Sodium	KROGER COMPANY	NDA	Current
30142-285	Naproxen Sodium	Naproxen Sodium	KROGER COMPANY	NDA	Current
30142-285	Naproxen Sodium	Naproxen Sodium	KROGER COMPANY	NDA	Current
30142-285	Naproxen Sodium	Naproxen Sodium	KROGER COMPANY	NDA	Current
36800-174	Naproxen Sodium	Naproxen Sodium	TOP CARE (Topco Associates LLC)	NDA	Current
36800-174	Naproxen Sodium	Naproxen Sodium	TOP CARE (Topco Associates LLC)	NDA	Current
36800-204	Naproxen Sodium	Naproxen Sodium	TOP CARE (Topco Associates LLC)	NDA	Current
36800-204	Naproxen Sodium	Naproxen Sodium	TOP CARE (Topco Associates LLC)	NDA	Current
36800-742	Topcare Naproxen Sodium	Naproxen sodium	Topco Associates LLC	NDA	Current
36800-742	Topcare Naproxen Sodium	Naproxen sodium	Topco Associates LLC	NDA	Current
37012-174	Naproxen Sodium	Naproxen Sodium	Shopko Stores Operating Co., LLC.	NDA	Current
37012-174	Naproxen Sodium	Naproxen Sodium	Shopko Stores Operating Co., LLC.	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-049	Naproxen Sodium	Naproxen Sodium	HEB	NDA	Current
37808-175	Naproxen Sodium	Naproxen Sodium	H E B	NDA	Current
37808-175	Naproxen Sodium	Naproxen Sodium	H E B	NDA	Current
37808-175	Naproxen Sodium	Naproxen Sodium	H E B	NDA	Current
41163-079	Naproxen Sodium	Naproxen Sodium	SUPERVALU INC	NDA	Current
41163-174	Naproxen Sodium	Naproxen Sodium	EQUALINE (SuperValu)	NDA	Current
41163-174	Naproxen Sodium	Naproxen Sodium	EQUALINE (SuperValu)	NDA	Current
41250-073	Naproxen Sodium	Naproxen Sodium	MEIJER, INC.	NDA	Current
41250-073	Naproxen Sodium	Naproxen Sodium	MEIJER, INC.	NDA	Current
41250-073	Naproxen Sodium	Naproxen Sodium	MEIJER, INC.	NDA	Current
41250-225	Naproxen Sodium	Naproxen Sodium	MEIJER DISTRIBUTION INC	NDA	Current
41250-225	Naproxen Sodium	Naproxen Sodium	MEIJER DISTRIBUTION INC	NDA	Current
41250-225	Naproxen Sodium	Naproxen Sodium	MEIJER DISTRIBUTION INC	NDA	Current
41250-225	Naproxen Sodium	Naproxen Sodium	MEIJER DISTRIBUTION INC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84781	SUPPL	2026-01-27
84782	SUPPL	2026-01-20
69587	SUPPL	2021-12-16
69586	SUPPL	2021-12-16
65594	SUPPL	2020-12-15
62790	SUPPL	2020-05-01
62789	SUPPL	2020-05-01
61993	SUPPL	2020-02-28
61992	SUPPL	2020-02-28
61227	SUPPL	2019-12-11
61223	SUPPL	2019-12-11
60695	SUPPL	2019-10-29
60694	SUPPL	2019-10-29
57769	SUPPL	2019-02-22
57739	SUPPL	2019-02-21
56821	SUPPL	2018-12-20
56633	SUPPL	2018-12-04
47595	SUPPL	2017-03-20
47573	SUPPL	2017-03-17
37876	SUPPL	2013-11-25
6449	SUPPL	2013-04-03
6448	SUPPL	2012-06-15
28843	SUPPL	2010-08-16
37875	SUPPL	2009-07-24
6447	SUPPL	2009-07-17
6446	SUPPL	2009-04-21
42350	ORIG	2008-02-22
23683	ORIG	2006-03-02
6445	ORIG	2006-03-01
16568	ORIG	2006-02-28