Home Applications 202027 Application 202027
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION;TOPICAL 1.5% No Yes
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 A202027-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27
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 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 cb3db0bc1861…
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Varophen DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE V2 Pharma, LLC 1bef5035-70ad-4f75-80c3-6252cd01fa85 2024-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202027 application number: ANDA202027 ndc (product): 72835-201
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-4016 Diclofenac Sodium Diclofenac Sodium A-S Medication Solutions ANDA Current 50436-3990 Diclofenac Sodium Diclofenac Sodium Unit Dose Services ANDA Current 60505-0399 Diclofenac Sodium Diclofenac Sodium Apotex Corp. ANDA Current 60505-0399 Diclofenac Sodium Diclofenac Sodium Apotex Corp. ANDA Current 60505-0399 Diclofenac Sodium Diclofenac Sodium Apotex Corp. ANDA Current 60505-0399 Diclofenac Sodium Diclofenac Sodium Apotex Corp. ANDA Current 60505-0399 Diclofenac Sodium Diclofenac Sodium Apotex Corp. ANDA Current 60505-0399 Diclofenac Sodium Diclofenac Sodium Apotex Corp. ANDA Current 61919-343 DICLOFENAC SODIUM DICLOFENAC SODIUM DIRECT RX ANDA Current 61919-343 DICLOFENAC SODIUM DICLOFENAC SODIUM DIRECT RX ANDA Current 68788-7097 Diclofenac Sodium Diclofenac Sodium Preferred Pharmaceuticals Inc. ANDA Current 69329-510 Diclotral Pak diclofenac sodium, capsaicin Patchwerx Labs, Inc. ANDA Current 69837-399 DICLOFENAC SODIUM DICLOFENAC SODIUM International Brand Management, LLC ANDA Current 69837-500 Sure Result DSS Premium Pak DICLOFENAC SODIUM, CAPSAICIN International Brand Management, LLC ANDA Current 70518-0572 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current 70518-0572 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current 70518-0572 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current 70518-0572 Diclofenac Sodium Diclofenac Sodium REMEDYREPACK INC. ANDA Current 72835-201 Varophen Diclofenac Sodium and Menthol, Methyl salicylate V2 Pharma, LLC ANDA Current 72835-201 Varophen Diclofenac Sodium and Menthol, Methyl salicylate V2 Pharma, LLC ANDA Current 72835-201 Varophen Diclofenac Sodium and Menthol, Methyl salicylate V2 Pharma, LLC ANDA Current