Home Applications 208077 Application 208077
Type ANDA
Sponsor AMNEAL PHARMS 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 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 A208077-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18
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 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 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 2 · 22 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac sodium DICLOFENAC SODIUM CVS Pharmacy 591cc2ed-e667-4779-a426-8a2e6f873573 2026-07-22 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 69842-974 Diclofenac sodium DICLOFENAC SODIUM CARDINAL HEALTH 110, LLC. DBA LEADER 70000 081b43f9-f594-4b1e-8564-7dbbea6fa5bd 2026-05-26 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 70000-0555 Diclofenac sodium DICLOFENAC SODIUM Walgreens 33a37e3d-0463-428c-9169-240eeb77af2b 2026-04-21 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 0363-1210 Diclofenac sodium DICLOFENAC SODIUM Rugby Laboratories 95f3c70c-eded-4d24-b9b0-cfa0b7902d6e 2026-02-10 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 0536-1294 Arthritis Pain Reliever DICLOFENAC SODIUM Family Dollar (FAMILY WELLNESS) 03ddf347-a3a3-4313-87d1-a246c1d4e0b4 2026-01-29 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Sportpharm LLC ac631742-119f-408a-8b36-b041bab743e2 2026-01-14 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM QUALITY CHOICE (Chain Drug Marketing Association) 98f94aa2-6bc2-4c07-81c8-63b2c262cf39 2026-01-06 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Safeway, Inc. 196d8af7-739f-4d2c-8c4e-9d33e6d722ab 2025-12-23 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 21130-028 Diclofenac sodium DICLOFENAC SODIUM Best Choice (Valu Merchandisers Company) 4ea809a9-387a-4193-a176-d8b22eaa55e6 2025-08-21 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 63941-812 Arthritis Pain Reliever DICLOFENAC SODIUM Chain Drug Consortium, LLC 8879a2ed-6c66-4489-8adc-9f160241cc7d 2025-06-25 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 68016-171 VennGel One DICLOFENAC SODIUM, ISOPROPYL ALCOHOL PureTek Corporation e0979152-132e-466b-8b56-87826f190c89 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 59088-709 Diclofenac sodium DICLOFENAC Scholl's Wellness Company 8dcbce69-945b-4913-a279-ee10871f6580 2024-11-14 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Salonpas DICLOFENAC SODIUM Hisamitsu America, Inc. f439445d-046e-4220-a4a7-13d750ee0949 2024-11-14 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 55328-801 Diclofenac sodium DICLOFENAC Amneal Pharmaceuticals NY LLC 1084e0c3-6d75-4090-84dc-02a18e0299b9 2023-12-29 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 69238-2053 Arthritis Pain Reliever DICLOFENAC SODIUM Care One (Retail Business Services, LLC.) 4484a332-aab1-46a9-aca8-159e7a09439f 2023-11-17 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM CVS PHARMACY, INC 4808015d-cfee-4f4d-a84b-82099f0b4868 2023-10-04 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 51316-073 Arthritis Pain Reliever DICLOFENAC SODIUM AmerisourceBergen (Good Neighbor Pharmacy) 46122 30e1f589-b322-48b7-9a97-502afe2a1baa 2023-08-09 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 2a7019e9-e20f-4897-9b8e-942a7f2b34f6 2023-02-21 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 49035-269 Diclofenac sodium DICLOFENAC SODIUM Costco Wholesale 141b6693-6d6c-45c6-9b82-ee1afcfca12a 2023-01-27 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM P & L Development, LLC 2596645a-b736-4d3c-82a0-00713f1b6fbd 2022-12-15 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 ndc (product): 59726-012
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 91 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-1210 Diclofenac sodium Diclofenac sodium Walgreens ANDA Current 0363-1210 Diclofenac sodium Diclofenac sodium Walgreens ANDA Current 0536-1294 Diclofenac sodium Diclofenac sodium Rugby Laboratories, Inc. ANDA Current 0536-1294 Diclofenac sodium Diclofenac sodium Rugby Laboratories, Inc. ANDA Current 0536-1294 Diclofenac sodium Diclofenac sodium Rugby Laboratories, Inc. ANDA Current 0536-1294 Diclofenac sodium Diclofenac sodium Rugby Laboratories, Inc. ANDA Current 0536-1294 Diclofenac sodium Diclofenac sodium Rugby Laboratories, Inc. ANDA Current 11822-7300 Arthritis Pain Reliever Diclofenac sodium Rite Aid Corporation ANDA Current 11822-7300 Arthritis Pain Reliever Diclofenac sodium Rite Aid Corporation ANDA Current 11822-8120 Arthritis Pain Reliever Diclofenac sodium Rite Aid Corporation ANDA Current 11822-8120 Arthritis Pain Reliever Diclofenac sodium Rite Aid Corporation ANDA Current 11822-8120 Arthritis Pain Reliever Diclofenac sodium Rite Aid Corporation ANDA Current 17856-0833 Diclofenac sodium Diclofenac ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-0833 Diclofenac sodium Diclofenac ATLANTIC BIOLOGICALS CORP. ANDA Current 21130-028 Diclofenac sodium Diclofenac sodium Safeway, Inc. ANDA Current 41250-973 Diclofenac sodium Diclofenac sodium MEIJER, INC. ANDA Current 41250-973 Diclofenac sodium Diclofenac sodium MEIJER, INC. ANDA Current 42291-256 Diclofenac sodium Diclofenac AvKARE, Inc. ANDA Current 42291-256 Diclofenac sodium Diclofenac AvKARE, Inc. ANDA Current 42291-256 Diclofenac sodium Diclofenac AvKARE ANDA Current 49035-269 Diclofenac sodium Diclofenac sodium EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-269 Diclofenac sodium Diclofenac sodium EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) ANDA Current 50090-2787 Diclofenac sodium Diclofenac A-S Medication Solutions ANDA Current 50090-2787 Diclofenac sodium Diclofenac A-S Medication Solutions ANDA Current 50090-4621 Diclofenac sodium Diclofenac A-S Medication Solutions ANDA Current 50268-237 Diclofenac sodium Diclofenac AvPAK ANDA Current 50436-0833 Diclofenac sodium Diclofenac Unit Dose Services ANDA Current 51316-012 Arthritis Pain Reliever Diclofenac sodium CVS PHARMACY, INC ANDA Current 51316-073 Arthritis Pain Reliever Diclofenac sodium CVS PHARMACY, INC ANDA Current 55328-801 Salonpas Diclofenac Sodium Hisamitsu America, Inc. ANDA Current 55328-801 Salonpas Diclofenac Sodium Hisamitsu America, Inc. ANDA Current 55700-675 Diclofenac sodium Diclofenac Lake Erie Medical DBA Quality Care Products LLC ANDA Current 55700-675 Diclofenac sodium Diclofenac Lake Erie Medical DBA Quality Care Products LLC ANDA Current 59088-709 VennGel One diclofenac sodium, isopropyl alcohol PureTek Corporation ANDA Current 59088-709 VennGel One diclofenac sodium, isopropyl alcohol PureTek Corporation ANDA Current 59088-709 VennGel One diclofenac sodium, isopropyl alcohol PureTek Corporation ANDA Current 59088-709 VennGel One diclofenac sodium, isopropyl alcohol PureTek Corporation ANDA Current 59088-709 VennGel One diclofenac sodium, isopropyl alcohol PureTek Corporation ANDA Current 59726-012 Arthritis Pain Reliever Diclofenac sodium P & L Development, LLC ANDA Current 59726-012 Arthritis Pain Reliever Diclofenac sodium P & L Development, LLC ANDA Current 59726-012 Arthritis Pain Reliever Diclofenac sodium P & L Development, LLC ANDA Current 63187-762 Diclofenac sodium Diclofenac Proficient Rx LP ANDA Current 63187-762 Diclofenac sodium Diclofenac Proficient Rx LP ANDA Current 63941-812 Diclofenac sodium Diclofenac sodium Best Choice (Valu Merchandisers Company) ANDA Current 63941-812 Diclofenac sodium Diclofenac sodium Best Choice (Valu Merchandisers Company) ANDA Current 63941-812 Diclofenac sodium Diclofenac sodium Best Choice (Valu Merchandisers Company) ANDA Current 63981-112 Diclofenac sodium Diclofenac sodium Costco Wholesale ANDA Current 63981-112 Diclofenac sodium Diclofenac sodium Costco Wholesale ANDA Current 63981-112 Diclofenac sodium Diclofenac sodium Costco Wholesale ANDA Current 65162-833 Diclofenac sodium Diclofenac Amneal Pharmaceuticals LLC ANDA Current 65162-833 Diclofenac sodium Diclofenac Amneal Pharmaceuticals LLC ANDA Current 65162-833 Diclofenac sodium Diclofenac Amneal Pharmaceuticals LLC ANDA Current 65162-833 Diclofenac sodium Diclofenac Amneal Pharmaceuticals LLC ANDA Current 68016-171 Arthritis Pain Reliever Diclofenac sodium Chain Drug Consortium, LLC ANDA Current 68016-171 Arthritis Pain Reliever Diclofenac sodium Chain Drug Consortium, LLC ANDA Current 68016-171 Arthritis Pain Reliever Diclofenac sodium Chain Drug Consortium, LLC ANDA Current 68071-3159 Diclofenac sodium Diclofenac NuCare Pharmaceuticals, Inc. ANDA Current 68071-4246 Diclofenac sodium Diclofenac NuCare Pharmaceuticals,Inc. ANDA Current 68788-6831 Diclofenac sodium Diclofenac Preferred Pharmaceuticals Inc. ANDA Current 68788-6831 Diclofenac sodium Diclofenac Preferred Pharmaceuticals Inc. ANDA Current 69238-2053 Diclofenac sodium Diclofenac Amneal Pharmaceuticals NY LLC ANDA Current 69238-2053 Diclofenac sodium Diclofenac Amneal Pharmaceuticals NY LLC ANDA Current 69238-2053 Diclofenac sodium Diclofenac Amneal Pharmaceuticals NY LLC ANDA Current 69256-012 Arthritis Pain Reliever Diclofenac sodium Harris Teeter, LLC ANDA Current 69256-012 Arthritis Pain Reliever Diclofenac sodium Harris Teeter, LLC ANDA Current 69256-012 Arthritis Pain Reliever Diclofenac sodium Harris Teeter, LLC ANDA Current 69336-827 DICLOZOR DICLOFENAC SODIUM Sterling-Knight Pharmaceuticals, LLC ANDA Current 69842-974 Diclofenac sodium Diclofenac sodium CVS Pharmacy ANDA Current 69842-974 Diclofenac sodium Diclofenac sodium CVS Pharmacy ANDA Current 69842-974 Diclofenac sodium Diclofenac sodium CVS Pharmacy ANDA Current 69842-974 Diclofenac sodium Diclofenac sodium CVS Pharmacy ANDA Current 69842-974 Diclofenac sodium Diclofenac sodium CVS Pharmacy ANDA Current 69842-974 Diclofenac sodium Diclofenac sodium CVS Pharmacy ANDA Current 70000-0555 Diclofenac sodium Diclofenac sodium Cardinal Health (Leader) 70000 ANDA Current 70000-0555 Diclofenac sodium Diclofenac sodium Cardinal Health (Leader) 70000 ANDA Current 70000-0555 Diclofenac sodium Diclofenac sodium Cardinal Health (Leader) 70000 ANDA Current 70518-1333 Diclofenac sodium Diclofenac REMEDYREPACK INC. ANDA Current 70518-1333 Diclofenac sodium Diclofenac REMEDYREPACK INC. ANDA Current 70518-1333 Diclofenac sodium Diclofenac REMEDYREPACK INC. ANDA Current 70518-1333 Diclofenac sodium Diclofenac REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57653 ORIG 2019-02-15