Home Applications 091353 Application 091353
Type ANDA
Sponsor GRANULES INDIA 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 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 A091353-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20
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 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091353-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091353-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 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 2 of 2 · 101 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68016-661 Naproxen Sodium Naproxen Sodium Pharmacy Valuce Alliance, LLC ANDA Current 68016-661 Naproxen Sodium Naproxen Sodium Pharmacy Valuce Alliance, LLC ANDA Current 68210-0040 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-0040 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-0040 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-0040 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-4096 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-4096 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-4096 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 68210-4096 NAPROXEN SODIUM NAPROXEN SODIUM SPIRIT PHARMACEUTICALS,LLC ANDA Current 69517-109 All Day Pain Relief Naproxen Sodium Tablets, 220 mg HealthLife of USA LLC ANDA Current 69848-009 Naproxen Sodium Naproxen Sodium Granules USA, Inc. ANDA Current 69848-009 Naproxen Sodium Naproxen Sodium Granules USA, Inc. ANDA Current 69848-009 Naproxen Sodium Naproxen Sodium Granules USA, Inc. ANDA Current 69848-010 Naproxen Sodium Naproxen Sodium Granules USA, Inc. ANDA Current 69848-010 Naproxen Sodium Naproxen Sodium Granules USA, Inc. ANDA Current 69848-010 Naproxen Sodium Naproxen Sodium Granules USA, Inc. ANDA Current 70005-008 All Day Pain Relief Naproxen Sodium Tablets, 220 mg We Care Distributor Inc. ANDA Current 71309-109 Naproxen Sodium Naproxen Sodium Safrel Pharmaceuticals, LLC. ANDA Current 82501-1576 Pain Relief Naproxen Sodium Gobrands, Inc ANDA Current 82501-1576 Pain Relief Naproxen Sodium Gobrands, Inc ANDA Current