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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A209484-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209484-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209484-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209484-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209484-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209484-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209484-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209484-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209484-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209484-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209484-001	AB	1	`ea99ee380514…`

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 3 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	Preferred Pharmaceuticals Inc.	ed1b5ec7-2812-4a81-90d1-953baa0b0ec8	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Aurolife Pharma LLC	dfb7afdf-5c05-4487-9044-936e151e5ba6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	5d0a4b41-afbf-45e7-bb1c-587d72314ee0	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	15b280a1-4964-4636-833b-3db44044d289	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	Preferred Pharmaceuticals Inc.	937e9ba5-cdad-4e72-a77a-bad699e1b236	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals, Inc.	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	e042e64c-5f18-4483-bcbd-dfd9b08a81cf	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL GEL, 1%,	Preferred Pharmaceuticals, Inc.	aee20924-79ab-400e-b9b6-418978914654	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
arthritis pain relieving	DICLOFENAC SODIUM	Walgreen Company	0da5d1d0-d8a4-4509-a098-e9c36d282474	2026-03-31	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	d349d286-b462-4f8f-aa39-6173653175d6	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	4ddd7e34-e5f4-8f05-e063-6294a90a70aa	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	663a3dbc-a631-4046-8852-ec619c41c81d	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DirectRx	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Direct_Rx	946b3799-2d56-12a5-e053-2a95a90aeba0	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Redpharm Drug	4cd2e51b-2019-6eb6-e063-6294a90ad7ef	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Edenbridge Pharmaceuticals LLC.	bd25a2b1-a4d5-4893-97d1-efdcd414a97d	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	337c2253-34c1-4611-88c9-d558507255a2	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	fae53d24-acf1-4250-888d-b8d965ffc3d3	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	942b4a76-1029-4cd7-9def-531ed33f3053	2026-02-17	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