Home Applications 208363 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 Product TE source text RLD / RS 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.
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 1 of 2 · 81 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0748 Naproxen Sodium Naproxen Sodium Walgreens ANDA Current 0363-0748 Naproxen Sodium Naproxen Sodium Walgreens ANDA Current 0363-0748 Naproxen Sodium Naproxen Sodium Walgreens ANDA Current 0363-0748 Naproxen Sodium Naproxen Sodium Walgreens ANDA Current 0363-0748 Naproxen Sodium Naproxen Sodium Walgreens ANDA Current 11673-748 Naproxen Sodium Naproxen Sodium TARGET Corporation ANDA Current 11673-748 Naproxen Sodium Naproxen Sodium TARGET Corporation ANDA Current 11673-748 Naproxen Sodium Naproxen Sodium TARGET Corporation ANDA Current 11673-748 Naproxen Sodium Naproxen Sodium TARGET Corporation ANDA Current 21130-748 Naproxen Sodium Naproxen Sodium Safeway, Inc. ANDA Current 21130-748 Naproxen Sodium Naproxen Sodium Safeway, Inc. ANDA Current 21130-748 Naproxen Sodium Naproxen Sodium Safeway, Inc. ANDA Current 21130-748 Naproxen Sodium Naproxen Sodium Safeway, Inc. ANDA Current 30142-748 Naproxen Sodium Naproxen Sodium The Kroger Co. ANDA Current 30142-748 Naproxen Sodium Naproxen Sodium The Kroger Co. ANDA Current 30142-748 Naproxen Sodium Naproxen Sodium The Kroger Co. ANDA Current 36800-748 Naproxen Sodium Naproxen Sodium TOP CARE (Topco Associates LLC) ANDA Current 36800-748 Naproxen Sodium Naproxen Sodium TOP CARE (Topco Associates LLC) ANDA Current 36800-748 Naproxen Sodium Naproxen Sodium TOP CARE (Topco Associates LLC) ANDA Current 36800-748 Naproxen Sodium Naproxen Sodium TOP CARE (Topco Associates LLC) ANDA Current 36800-748 Naproxen Sodium Naproxen Sodium TOP CARE (Topco Associates LLC) ANDA Current 37012-748 Naproxen Sodium Naproxen Sodium Shopko Stores Operating Co., LLC. ANDA Current 37012-748 Naproxen Sodium Naproxen Sodium Shopko Stores Operating Co., LLC. ANDA Current 41520-748 Naproxen Sodium Naproxen Sodium Care One (American Sales Company) ANDA Current 41520-748 Naproxen Sodium Naproxen Sodium Care One (American Sales Company) ANDA Current 41520-748 Naproxen Sodium Naproxen Sodium Care One (American Sales Company) ANDA Current 46122-534 Naproxen Sodium Naproxen Sodium AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-534 Naproxen Sodium Naproxen Sodium AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-534 Naproxen Sodium Naproxen Sodium AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 46122-534 Naproxen Sodium Naproxen Sodium AmerisourceBergen (Good Neighbor Pharmacy) 46122 ANDA Current 49035-748 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-748 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-748 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-748 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) ANDA Current 51013-137 NAPROXEN SODIUM Naproxen Sodium PuraCap Pharmaceutical LLC ANDA Current 51013-137 NAPROXEN SODIUM Naproxen Sodium PuraCap Pharmaceutical LLC ANDA Current 53345-042 NAPROXEN SODIUM Naproxen Sodium Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd ANDA Current 53345-042 NAPROXEN SODIUM Naproxen Sodium Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd ANDA Current 55301-748 Naproxen Sodium Naproxen Sodium AAFES/Your Military Exchanges ANDA Current 55301-748 Naproxen Sodium Naproxen Sodium AAFES/Your Military Exchanges ANDA Current 55301-748 Naproxen Sodium Naproxen Sodium AAFES/Your Military Exchanges ANDA Current 55315-748 Naproxen Sodium Naproxen Sodium Freds Inc ANDA Current 55315-748 Naproxen Sodium Naproxen Sodium Freds Inc ANDA Current 55319-748 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55319-748 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) NDA Current 55319-748 Naproxen Sodium Naproxen Sodium Family Dollar (FAMILY WELLNESS) ANDA Current 55910-748 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-748 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-748 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-748 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 55910-748 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ANDA Current 56062-748 All Day Relief Naproxen Sodium Publix Supermarkets, Inc. ANDA Current 56062-748 All Day Relief Naproxen Sodium Publix Supermarkets, Inc. ANDA Current 56062-748 All Day Relief Naproxen Sodium Publix Supermarkets, Inc. ANDA Current 56062-748 All Day Relief Naproxen Sodium Publix Supermarkets, Inc. ANDA Current 59726-174 Naproxen Sodium Naproxen Sodium P & L Development, LLC ANDA Current 59726-174 Naproxen Sodium Naproxen Sodium P & L Development, LLC ANDA Current 59726-174 Naproxen Sodium Naproxen Sodium P & L Development, LLC NDA Current 59726-174 Naproxen Sodium Naproxen Sodium P & L Development, LLC ANDA Current 59726-748 Naproxen Sodium Naproxen Sodium P & L Development, LLC ANDA Current 59726-748 Naproxen Sodium Naproxen Sodium P & L Development, LLC ANDA Current 62011-0369 Naproxen Sodium Naproxen Sodium McKesson (Health Mart) ANDA Current 62011-0369 Naproxen Sodium Naproxen Sodium Strategic Sourcing Services LLC ANDA Current 62011-0369 Naproxen Sodium Naproxen Sodium Strategic Sourcing Services LLC ANDA Current 62011-0369 Naproxen Sodium Naproxen Sodium Strategic Sourcing Services LLC ANDA Current 62011-0369 Naproxen Sodium Naproxen Sodium McKesson (Health Mart) ANDA Current 69230-305 Naproxen Sodium Naproxen Sodium Camber Consumer Care ANDA Current 69230-305 Naproxen Sodium Naproxen Sodium Camber Consumer Care ANDA Current 69230-305 Naproxen Sodium Naproxen Sodium Camber Consumer Care ANDA Current 69230-305 Naproxen Sodium Naproxen Sodium Camber Consumer Care ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 69842-748 Naproxen Sodium Naproxen Sodium CVS Pharmacy ANDA Current 72476-748 Naproxen Sodium Naproxen Sodium Care One (Retail Business Services, LLC.) ANDA Current 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