Home Applications 209484 Application 209484
Type ANDA
Sponsor HI TECH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL;TOPICAL 1% 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 A209484-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21
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 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2018-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209484-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2018-11-21 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 15 of 16 · 312 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac sodium DICLOFENAC SODIUM Costco Wholesale 141b6693-6d6c-45c6-9b82-ee1afcfca12a 2023-01-27 Warnings Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM DICLOFENAC SODIUM DICLOFENAC SODIUM TOPICAL GEL, 1% Proficient Rx LP b4694451-a13d-484e-92c4-c03a6fcbb511 2023-01-01 Warnings Name fallback brand name: DICLOFENAC SODIUM Diclofenac sodium DICLOFENAC SODIUM Proficient Rx LP b98d921a-2ee7-4770-ac21-d845b2dcc11c 2023-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM Arthritis Pain Reliever DICLOFENAC SODIUM P & L Development, LLC 2596645a-b736-4d3c-82a0-00713f1b6fbd 2022-12-15 Warnings Name fallback generic name: DICLOFENAC SODIUM Diclofenac DICLOFENAC SODIUM Altaire Pharmaceuticals Inc. 5372866a-dab3-45c8-8c2a-755ca36c1791 2022-10-28 Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC Asclemed USA, Inc. 9df599de-6412-a94e-e053-2995a90a1741 2022-10-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium Diclofenac sodium DICLOFENAC SODIUM Asclemed USA, Inc. d4b81a74-6926-4715-bf90-aec026cff2b4 2022-09-09 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Asclemed USA, Inc. b162d65d-b105-4a68-90bb-316b9686267b 2022-08-24 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Rite Aid Corporation 1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f 2022-08-23 Warnings Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM diclofenac sodium DICLOFENAC SODIUM Proficient Rx LP 67e384c6-8476-4aad-b967-241335538d56 2022-08-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: diclofenac sodium generic name: DICLOFENAC SODIUM Diclofenac Sodium Delayed Release DICLOFENAC SODIUM Proficient Rx LP afce2de2-0c59-4191-bf79-782ca31e427d 2022-07-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM A-S Medication Solutions 3a520306-fe3e-4830-963f-04b080db3abc 2022-06-01 Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM good sense arthritis pain DICLOFENAC SODIUM Proficient Rx LP 67eacd91-8378-47e7-9bad-1e7b685aa9d4 2022-06-01 Warnings Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Proficient Rx LP 9eeb2aef-3eb1-4583-8180-d480deb3651c 2022-05-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Proficient Rx LP 1c1ee94c-60d6-4cfc-bb66-1d4f6e630512 2022-05-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM Diclofenac Sodium Delayed Release DICLOFENAC SODIUM Proficient Rx LP 947c0c1f-3573-4f69-ab82-8b50c43e5586 2022-04-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: DICLOFENAC SODIUM Arthritis Pain Reliever DICLOFENAC SODIUM CVS PHARMACY, INC 047985ea-f768-4f9a-bfe3-0acf40a4781d 2022-02-15 Warnings Name fallback generic name: DICLOFENAC SODIUM basic care arthritis pain DICLOFENAC SODIUM Amazon.com Services LLC a8aa9016-bf2d-4727-9184-512b2570000b 2022-01-06 Warnings Name fallback generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Sandoz Inc 52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b 2021-09-29 Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM Diclofenac Sodium DICLOFENAC SODIUM Actavis Pharma, Inc. a57b897e-0cbe-4ac3-969f-b00357a0cfa8 2021-08-10 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
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 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50383-272 Diclofenac Sodium Diclofenac Sodium Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-272 Diclofenac Sodium Diclofenac Sodium Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-272 Diclofenac Sodium Diclofenac Sodium Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-528 Diclofenac Sodium Diclofenac Sodium Akorn ANDA Current 70518-2673 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current 70518-2673 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current 70518-2673 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current