Home Applications 021920 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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N021920-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL RLD, RS 2006-02-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021920-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL RLD, RS 2006-02-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021920-001 NAPROXEN SODIUM EQ 200MG BASE CAPSULE / ORAL RLD, RS 2006-02-17 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 9 · 337 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021920-001 10022344 2026-03-03 U-1731 Drug product 2018-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 10022344 2026-03-03 U-1732 Drug product 2018-07-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 10028925 2026-03-03 U-1731 Drug product 2018-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 10028925 2026-03-03 U-1732 Drug product 2018-07-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 11090280 2026-03-03 U-1731 Drug product 2021-08-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 11090280 2026-03-03 U-1732 Drug product 2021-08-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 9693978 2026-03-03 Drug product 2017-11-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021920-001 9693979 2026-03-03 Drug product 2017-11-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021920-001 10022344 2026-03-03 U-1731 Drug product 2018-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 10022344 2026-03-03 U-1732 Drug product 2018-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 10028925 2026-03-03 U-1731 Drug product 2018-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 10028925 2026-03-03 U-1732 Drug product 2018-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 11090280 2026-03-03 U-1731 Drug product 2021-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 11090280 2026-03-03 U-1732 Drug product 2021-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 9693978 2026-03-03 Drug product 2017-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021920-001 9693979 2026-03-03 Drug product 2017-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021920-001 10022344 2026-03-03 U-1731 Drug product 2018-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 10022344 2026-03-03 U-1732 Drug product 2018-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 10028925 2026-03-03 U-1731 Drug product 2018-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 10028925 2026-03-03 U-1732 Drug product 2018-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 11090280 2026-03-03 U-1731 Drug product 2021-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 11090280 2026-03-03 U-1732 Drug product 2021-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 9693978 2026-03-03 Drug product 2017-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021920-001 9693979 2026-03-03 Drug product 2017-11-13 caaa826d4ba7…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…
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 2 of 2 · 21 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 2 of 2 · 145 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 41250-225 Naproxen Sodium Naproxen Sodium MEIJER DISTRIBUTION INC NDA Current 41520-075 Naproxen Sodium Naproxen Sodium Care One (American Sales Company) NDA Current 41520-075 Naproxen Sodium Naproxen Sodium Care One (American Sales Company) NDA Current 42507-174 Naproxen Sodium Naproxen Sodium Hy-Vee NDA Current 42507-174 Naproxen Sodium Naproxen Sodium Hy-Vee NDA Current 42507-174 Naproxen Sodium Naproxen Sodium Hy-Vee NDA Current 42507-174 Naproxen Sodium Naproxen Sodium Hy-Vee NDA Current 46122-038 Good Neighbor Pharmacy Naproxen Sodium Naproxen sodium Amerisource Bergen NDA Current 46122-038 Good Neighbor Pharmacy Naproxen Sodium Naproxen sodium Amerisource Bergen NDA Current 46122-283 Naproxen Sodium Naproxen Sodium AmerisourceBergen (Good Neighbor Pharmacy) 46122 NDA Current 49035-075 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) NDA Current 49035-075 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) NDA Current 49035-075 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) NDA Current 49035-098 Equate Naproxen Sodium Naproxen sodium Wal-Mart Stores Inc NDA Current 49035-382 Naproxen Sodium Naproxen Sodium Wal-Mart Stores, Inc. NDA Current 49035-382 Naproxen Sodium Naproxen Sodium Wal-Mart Stores, Inc. NDA Current 49035-382 Naproxen Sodium Naproxen Sodium Wal-Mart Stores, Inc. NDA Current 49035-974 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) NDA Current 49035-974 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) NDA Current 49035-974 Naproxen Sodium Naproxen Sodium EQUATE (Wal-Mart Stores, Inc.) NDA Current 49348-940 Sunmark Naproxen Sodium Naproxen sodium McKesson NDA Current 49348-940 Sunmark Naproxen Sodium Naproxen sodium Strategic Sourcing Services LLC NDA Current 49738-174 Naproxen Sodium Naproxen Sodium SMART SENSE (Kmart) NDA Current 49738-174 Naproxen Sodium Naproxen Sodium SMART SENSE (Kmart) NDA Current 53943-179 Naproxen Sodium Naproxen Sodium DISCOUNT DRUG MART, INC. NDA Current 53943-179 Naproxen Sodium Naproxen Sodium DISCOUNT DRUG MART, INC. NDA Current 53943-179 Naproxen Sodium Naproxen Sodium DISCOUNT DRUG MART, INC. NDA Current 53943-179 Naproxen Sodium Naproxen Sodium DISCOUNT DRUG MART, INC. NDA Current 55301-174 Naproxen Sodium Naproxen Sodium AAFES/Your Military Exchanges NDA Current 55301-174 Naproxen Sodium Naproxen Sodium AAFES/Your Military Exchanges NDA Current 55312-174 Naproxen Sodium Naproxen Sodium Western Family Foods, Inc. NDA Current 55316-175 Naproxen Sodium Naproxen Sodium Healthy Accents (DZA Brands, LLC) NDA Current 55316-175 Naproxen Sodium Naproxen Sodium Healthy Accents (DZA Brands, LLC) NDA Current 55319-174 All Day Pain Relief Naproxen Sodium Family Dollar (FAMILY WELLNESS) NDA Current 55319-174 All Day Pain Relief Naproxen Sodium Family Dollar (FAMILY WELLNESS) NDA Current 55319-174 All Day Pain Relief Naproxen Sodium Family Dollar (FAMILY WELLNESS) NDA Current 55910-075 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) NDA Current 55910-075 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) NDA Current 55910-075 Naproxen Sodium Naproxen Sodium Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) NDA Current 56062-174 Naproxen Sodium Naproxen Sodium Publix Supermarkets, Inc. NDA Current 56062-174 Naproxen Sodium Naproxen Sodium Publix Supermarkets, Inc. NDA Current 56062-174 Naproxen Sodium Naproxen Sodium Publix Supermarkets, Inc. NDA Current 59779-353 Naproxen Sodium Naproxen Sodium CVS Pharmacy NDA Current 59779-353 Naproxen Sodium Naproxen Sodium CVS Pharmacy NDA Current 59779-353 Naproxen Sodium Naproxen Sodium CVS Pharmacy NDA Current 62011-0249 Naproxen Sodium Naproxen Sodium McKesson (Health Mart) NDA Current 62011-0249 Naproxen Sodium Naproxen Sodium Strategic Sourcing Services LLC NDA Current 63868-123 Naproxen Sodium Naproxen Sodium QUALITY CHOICE (Chain Drug Marketing Association) NDA Current 63868-830 Naproxen Sodium Naproxen Sodium CHAIN DRUG MARKETING ASSOCIATION INC. NDA Current 63868-830 Naproxen Sodium Naproxen Sodium CHAIN DRUG MARKETING ASSOCIATION INC. NDA Current 63940-174 All Day Pain Relief Naproxen Sodium Harmon Stores NDA Current 63940-174 All Day Pain Relief Naproxen Sodium Harmon Stores NDA Current 68016-056 Naproxen Sodium Naproxen Sodium Premier Value Alliance LLC NDA Current 69452-179 Naproxen Sodium Naproxen Sodium Bionpharma Inc. NDA Current 69452-179 Naproxen Sodium Naproxen Sodium Bionpharma Inc. NDA Current 69452-179 Naproxen Sodium Naproxen Sodium Bionpharma Inc. NDA Current 69452-179 Naproxen Sodium Naproxen Sodium Bionpharma Inc. NDA Current 69452-259 naproxen sodium naproxen sodium Bionpharma Inc. NDA Current 69452-259 naproxen sodium naproxen sodium Bionpharma Inc. NDA Current 69452-259 naproxen sodium naproxen sodium Bionpharma Inc. NDA Current 69452-284 naproxen sodium naproxen sodium Bionpharma Inc. NDA Current 69452-284 naproxen sodium naproxen sodium Bionpharma Inc. NDA Current 69842-975 Naproxen Sodium Naproxen Sodium CVS Pharmacy NDA Current 69842-975 Naproxen Sodium Naproxen Sodium CVS Pharmacy NDA Current 69842-975 Naproxen Sodium Naproxen Sodium CVS Pharmacy NDA Current