Home Applications 075168 Application 075168
Type ANDA
Sponsor DR REDDYS LABS INC 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 A075168-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28
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 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075168-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1998-07-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075168-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1998-07-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075168-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1998-07-28 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 1 · 6 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 30142-954 Naproxen Sodium Naproxen Sodium Kroger Company ANDA Current 30142-954 Naproxen Sodium Naproxen Sodium Kroger Company ANDA Current 30142-954 Naproxen Sodium Naproxen Sodium Kroger Company ANDA Current 43598-058 Naproxen Sodium Naproxen Sodium Dr Reddy's Laboratories Inc ANDA Current 43598-058 Naproxen Sodium Naproxen Sodium Dr Reddy's Laboratories Inc ANDA Current 43598-058 Naproxen Sodium Naproxen Sodium Dr Reddy's Laboratories Inc ANDA Current 43598-059 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-059 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-059 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-060 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-060 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-060 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-071 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-071 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-072 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-072 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-073 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-073 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-074 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 43598-074 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Inc ANDA Current 55111-272 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Limited ANDA Current 55111-272 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Limited ANDA Current 55111-272 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Limited ANDA Current 55111-273 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Limited ANDA Current 55111-273 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Limited ANDA Current 55111-273 Naproxen Sodium Naproxen Sodium Dr.Reddy's Laboratories Limited ANDA Current 68196-255 Naproxen Sodium Naproxen Sodium SAM'S WEST INC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30780 ORIG 1998-07-28