Application 020037

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOLTAREN	DICLOFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	0.1%	Yes	Yes

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
N020037-001	VOLTAREN	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28

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 · 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	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1991-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020037-001	VOLTAREN	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD	1991-03-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020037-001	AT	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020037-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020037-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020037-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020037-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020037-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020037-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020037-001	AT	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 4 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	99f1e69e-02cf-49c2-83af-3cccbbea4215	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	0cefb675-c54e-44eb-b35c-38354b77eddd	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	A-S Medication Solutions	74011b00-7e2e-40a7-ab30-c05a20559814	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Umedica Laboratories USA Inc.	0e5c6669-390f-4c32-b9b8-13ed3c517462	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Arthritis Pain Reliever	DICLOFENAC SODIUM	Family Dollar (FAMILY WELLNESS)	03ddf347-a3a3-4313-87d1-a246c1d4e0b4	2026-01-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	468fab22-2b69-4a2c-e063-6294a90aab9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bausch & Lomb Incorporated	39dfffb0-612a-48f3-8db5-1a59899b91e9	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Ingenus Pharmaceuticals, LLC	1a237198-ca24-4159-b570-b5a23c8e91b0	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	4ee64a93-9965-47c8-be2c-14232df44b2b	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	f92576d7-3ad9-43a3-8b10-3a29fbf712a4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	A-S Medication Solutions	6c57e330-ebbe-4165-84a8-4844b2f0097e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Publix Super Markets Inc	bae07276-c800-468e-a201-e6268846fff3	2026-01-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	47793dca-5e9e-44ee-8e66-5e42e1831b1e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	b74be49d-74ff-491b-962b-0edd3a57cbc9	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM TOPICAL	DICLOFENAC SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	181e32ab-5ec0-4be4-bad0-b6bbafc08f85	2026-01-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	929f71ab-f0c8-4331-800d-ed4a172e647e	2026-01-14	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	ac631742-119f-408a-8b36-b041bab743e2	2026-01-14	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	AvKARE	19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	AvKARE	0416ce03-c345-9d9e-e063-6294a90ad940	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Aspercreme Arthritis	DICLOFENAC SODIUM	Chattem, Inc.	81f78685-c416-48b5-8840-eef03a66bc28	2026-01-12	Warnings	Name fallback 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0478	VOLTAREN	diclofenac sodium	Novartis Pharmaceutical Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
34203	SUPPL	2012-09-14
1945	SUPPL	2012-09-14
21072	SUPPL	2011-04-13
34202	SUPPL	2011-04-11
21071	SUPPL	2007-09-06
12159	SUPPL	2007-09-06