Home Applications 090545 Application 090545
Type ANDA
Sponsor MARKSANS PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL 220MG No No
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 A090545-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 cb3db0bc1861…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 85 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-6099 ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS ANDA Current 0363-9608 ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS ANDA Current 0363-9608 ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS ANDA Current 0363-9608 ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS ANDA Current 0363-9608 ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS ANDA Current 0363-9608 ALL DAY PAIN RELIEF NAPROXEN SODIUM WALGREENS ANDA Current 0363-9609 BACK AND MUSCLE PAIN NAPROXEN WALGREENS ANDA Current 0363-9609 BACK AND MUSCLE PAIN NAPROXEN WALGREENS ANDA Current 0536-1022 All Day Relief Naproxen Sodium, Coated Tablets Rugby Laboratories ANDA Current 0536-1023 All Day Relief Naproxen Sodium Tablet, coated Rugby Laboratories ANDA Current 25000-141 Naproxen Sodium Naproxen Sodium, Coated Tablets MARKSANS PHARMA LIMITED ANDA Current 25000-141 Naproxen Sodium Naproxen Sodium, Coated Tablets MARKSANS PHARMA LIMITED ANDA Current 25000-141 Naproxen Sodium Naproxen Sodium, Coated Tablets MARKSANS PHARMA LIMITED ANDA Current 25000-144 Naproxen Sodium Naproxen Sodium Tablet, coated MARKSANS PHARMA LIMITED ANDA Current 25000-144 Naproxen Sodium Naproxen Sodium Tablet, coated MARKSANS PHARMA LIMITED ANDA Current 25000-144 Naproxen Sodium Naproxen Sodium Tablet, coated MARKSANS PHARMA LIMITED ANDA Current 27854-505 Flanax Pain Reliever/Fever reducer Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 27854-555 Belmora Flanax Naproxen Sodium Belmora LLC ANDA Current 35418-000 Naproxen Naproxen Sodium Zee Medical Inc ANDA Current 41226-609 NAPROXEN SODIUM NAPROXEN SODIUM Kroger Company ANDA Current 48201-007 CALMADOL PAIN RELIEVER Naproxen Sodium Grandall Distributing Co., Inc. ANDA Current 48201-007 CALMADOL PAIN RELIEVER Naproxen Sodium Grandall Distributing Co., Inc. ANDA Current 48201-007 CALMADOL PAIN RELIEVER Naproxen Sodium Grandall Distributing Co., Inc. ANDA Current 49483-608 NAPROXEN SODIUM NAPROXEN SODIUM TIME CAP LABORATORIES, INC ANDA Current 49483-608 NAPROXEN SODIUM NAPROXEN SODIUM TIME CAP LABORATORIES, INC ANDA Current 49483-609 NAPROXEN SODIUM NAPROXEN SODIUM TIME CAP LABORATORIES, INC ANDA Current 49483-609 NAPROXEN SODIUM NAPROXEN SODIUM TIME CAP LABORATORIES, INC ANDA Current 51824-030 CAREALL Naproxen Naproxen Sodium New World Imports, Inc. ANDA Current 52605-141 Naproxen Sodium Naproxen Sodium Polygen Pharmaceuticals LLC ANDA Current 52605-144 Naproxen Sodium Naproxen Sodium Polygen Pharmaceuticals LLC ANDA Current 53185-362 Naproxen Sodium 220mg Naproxen Sodium 220mg Athlete's Needs, Inc. ANDA Current 53185-362 Naproxen Sodium 220mg Naproxen Sodium 220mg Athlete's Needs, Inc. ANDA Current 53185-362 Naproxen Sodium 220mg Naproxen Sodium 220mg Athlete's Needs, Inc. ANDA Current 53185-394 Naproxen Sodium 220mg Naproxen Sodium 220mg Athlete's Needs, Inc. ANDA Current 53185-394 Naproxen Sodium 220mg Naproxen Sodium 220mg Athlete's Needs, Inc. ANDA Current 53185-394 Naproxen Sodium 220mg Naproxen Sodium 220mg Athlete's Needs, Inc. ANDA Current 53329-688 Naproxen Sodium 220mg Naproxen Sodium Medline Industries ANDA Current 53329-688 Naproxen Sodium 220mg Naproxen Sodium Medline Industries ANDA Current 53329-688 Naproxen Sodium 220mg Naproxen Sodium Medline Industries ANDA Current 53329-688 Naproxen Sodium 220mg Naproxen Sodium Medline Industries, LP ANDA Current 53329-688 Naproxen Sodium 220mg Naproxen Sodium Medline Industries, LP ANDA Current 57896-951 Naproxen Sodium Naproxen Sodium Geri-Care Pharmaceutical Corp ANDA Current 59105-003 NAPROXEN SODIUM NAPROXEN SODIUM J.P. BUSINESS ENTERPRISE ANDA Current 61919-470 NAPROXEN SODIUM NAPROXEN SODIUM DIRECT RX ANDA Current 61919-470 NAPROXEN SODIUM NAPROXEN SODIUM DIRECT RX ANDA Current 61919-470 NAPROXEN SODIUM NAPROXEN SODIUM DIRECT RX ANDA Current 63187-986 Naproxen Sodium Naproxen Sodium Proficient Rx LP ANDA Current 63187-986 Naproxen Sodium Naproxen Sodium Proficient Rx LP ANDA Current 63629-7773 Naproxen Sodium Naproxen Sodium Bryant Ranch Prepack ANDA Current 63629-7773 Naproxen Sodium Naproxen Sodium Bryant Ranch Prepack ANDA Current 67060-000 NAPROXEN SODIUM NAPROXEN SODIUM ADVANCED FIRST AID, INC. ANDA Current 68071-3223 Naproxen Sodium Naproxen Sodium NuCare Pharmaceuticals,Inc. ANDA Current 68210-0030 ALL DAY PAIN RELIEF NAPROXEN SODIUM SPIRIT PHARMACEUTICALS LLC ANDA Current 68210-0030 ALL DAY PAIN RELIEF NAPROXEN SODIUM SPIRIT PHARMACEUTICALS LLC ANDA Current 68210-0400 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-0400 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-0400 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-0400 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68788-7367 Naproxen Sodium Naproxen Sodium Preferred Pharmaceuticals Inc. ANDA Current 68788-7367 Naproxen Sodium Naproxen Sodium Preferred Pharmaceuticals Inc. ANDA Current 68788-7367 Naproxen Sodium Naproxen Sodium Preferred Pharmaceuticals Inc. ANDA Current 68788-9971 All Day Relief Naproxen Sodium Tablet, coated Preferred Pharmaceuticals Inc. ANDA Current 69168-361 Naproxen Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-361 Naproxen NAPROXEN SODIUM 220 MG Allegiant Health ANDA Current 69168-362 Naproxen Caplets Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-362 Naproxen Caplets Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-362 Naproxen Caplets Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-394 Naproxen Caplets Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-394 Naproxen Caplets Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-394 Naproxen Caplets Naproxen Sodium 220 mg Allegiant Health ANDA Current 69168-395 Naproxen Sodium 220mg Naproxen Sodium 220mg Allegiant Health ANDA Current 69168-395 Naproxen Sodium 220mg Naproxen Sodium 220mg Allegiant Health ANDA Current 69168-395 Naproxen Sodium 220mg Naproxen Sodium 220mg Allegiant Health ANDA Current 69168-632 Naproxen Sodium Naproxen Sodium 220mg Allegiant Health ANDA Current