Application 208363

Type: ANDA
Sponsor: PURACAP PHARM LLC

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	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208363-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL			2018-03-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`f41ea6bd6efb…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36ce5cd9-8c61-4ed9-b840-c29ad98bdfc5	2026-08-20	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c28c4fd2-1428-421c-b62f-265e472d833e	2026-07-09	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	c194124b-a5f6-423e-bc9a-7b611df990a8	2026-05-13	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	d9806ad8-1cea-4599-97ef-a956ec7f0e21	2026-03-11	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc.	deb1be0f-64ae-46b5-b54a-1a58eec6492e	2026-01-05	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	fc65fe79-c93b-4247-b9af-e562792a3e64	2025-08-19	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	AAFES/Your Military Exchanges	c387f7cb-7cc4-4989-9f9a-bb00a895fd0d	2025-05-08	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Care One (Retail Business Services, LLC.)	5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad	2024-02-21	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363 ndc (product): 72476-748
All Day Relief	NAPROXEN SODIUM	Publix Supermarkets, Inc.	4db86c5b-62bb-4638-9f1e-98dc2680d6cc	2024-01-23	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Strategic Sourcing Services LLC	435e55b2-3d75-4a1e-9f00-69b29baf37af	2023-10-02	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Care One (American Sales Company)	043f7032-4e83-4642-93a8-6c09de26b43f	2022-11-21	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de03311d-fb58-43f5-a110-aac9a39c9132	2022-11-07	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
NAPROXEN SODIUM	NAPROXEN SODIUM	PuraCap Pharmaceutical LLC	fc865e81-164c-48e9-8fb9-6fc27d1c33cf	2019-12-10	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
NAPROXEN SODIUM	NAPROXEN SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	1d5981dd-e3f5-48a3-a5f1-ce49689cdfac	2019-11-08	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72476-748	Naproxen Sodium	Naproxen Sodium	Care One (Retail Business Services, LLC.)	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57669	ORIG	2019-02-15