Application 020037
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOLTAREN | DICLOFENAC SODIUM | SOLUTION/DROPS;OPHTHALMIC | 0.1% | Yes | Yes |
Orange Book products#
| 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.
| 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 | 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… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020037-001 | VOLTAREN | 0.1% | SOLUTION/DROPS / OPHTHALMIC | RLD | 1991-03-28 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020037-001 | VOLTAREN | 0.1% | SOLUTION/DROPS / OPHTHALMIC | RLD | 1991-03-28 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 681b6b25-4a28-44f2-8042-d5e01a502116 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals, Inc. | 57c83158-f072-6fa2-e063-6394a90aee2c | 2026-07-29 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | ddd2278b-70be-41ca-8a84-e3fe0f1a1561 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | CVS Pharmacy | 591cc2ed-e667-4779-a426-8a2e6f873573 | 2026-07-22 | Warnings | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Aurobindo Pharma Limited | d9b6f1d0-1710-46fb-8ea4-80b3ca60a575 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | HAWAII REPACK, INC | ea113a58-c7ed-4768-9777-93d9b166dfbe | 2026-07-12 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | American Health Packaging | 63c00b50-06d3-4659-81cf-be4516429e81 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | REMEDYREPACK INC. | 6e6a6f98-5517-4f67-9a6a-71019ba2d773 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 71a823c4-9c88-474d-b525-276f9e7808aa | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 09643e65-f301-4891-96f4-d78bf3621e23 | 2026-07-02 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 30c7e4fd-30af-4d28-a6ef-7386ff83cfb8 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | American Health Packaging | dbb1489d-b690-4e53-905d-7fb07ad263b3 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| ARTHRITIS PAIN RELIEF | DICLOFENAC SODIUM | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 84978746-4ab5-456d-af63-5c86ab0a05f5 | 2026-06-29 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 10991fe6-fafd-49af-9684-83b447c19c67 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | REMEDYREPACK INC. | 6980431d-4a2b-41e9-ae86-d46b4513f04b | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | ASCLEMED USA INC. | 53e8ad44-ff67-d3bb-e063-6394a90a524d | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | St. Mary's Medical Park Pharmacy | 5f4b69de-8ddd-26c5-e053-2a91aa0ab326 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Golden State Medical Supply, Inc. | c1d87003-f54b-4381-9e11-1c39ea2d9eb3 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 081b43f9-f594-4b1e-8564-7dbbea6fa5bd | 2026-05-26 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 1eb7a7bb-c524-4168-8ade-4601dc11533b | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0478 | VOLTAREN | diclofenac sodium | Novartis Pharmaceutical Corporation | NDA | Current |