Application 074514
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG | No | No |
| 002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074514-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | |
| A074514-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074514-001 | AB |
| A074514-002 | AB |
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 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074514-001 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074514-002 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1996-03-26 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A074514-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074514-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074514-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074514-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074514-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074514-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074514-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074514-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074514-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074514-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074514-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074514-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074514-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074514-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074514-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074514-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074514-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074514-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074514-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074514-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074514-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074514-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074514-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074514-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074514-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074514-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074514-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A074514-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074514-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074514-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074514-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A074514-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074514-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A074514-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074514-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074514-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074514-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A074514-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074514-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A074514-002 | AB | 1 | 782e0a99824c… |
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 | Golden State Medical Supply, Inc. | c1d87003-f54b-4381-9e11-1c39ea2d9eb3 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 60429-422 60429-421 |
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 663a3dbc-a631-4046-8852-ec619c41c81d | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 43063-467 |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 47793dca-5e9e-44ee-8e66-5e42e1831b1e | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 50090-1769 50090-0539 |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | b74be49d-74ff-491b-962b-0edd3a57cbc9 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 50090-0538 |
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 87d5a720-f154-4c4b-b2d4-0ae58455dda0 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 55289-150 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | f5b4e308-c156-4865-95ee-1a8e267535ba | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 63187-522 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Actavis Pharma, Inc. | a57b897e-0cbe-4ac3-969f-b00357a0cfa8 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 0228-2551 0228-2550 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 77c3cb56-c071-4d92-a0d6-022417a27de4 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 63187-761 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Aphena Pharma Solutions - Tennessee, LLC | e4af374a-1281-46af-a0a9-48820db6c947 | 2018-05-31 | Boxed warning, Warnings, Adverse reactions | 074514 ANDA074514 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2550 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2551 | Diclofenac Sodium | Diclofenac Sodium | Actavis Pharma, Inc. | ANDA | Current |
| 0615-4506 | diclofenac sodium | diclofenac sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-4507 | diclofenac sodium | diclofenac sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-114 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc | ANDA | Current |
| 10544-921 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc | ANDA | Current |
| 10544-923 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-038 | diclofenac sodium | diclofenac sodium | Rebel Distributors Corp | ANDA | Current |
| 21695-039 | diclofenac sodium | diclofenac sodium | Rebel Distributors Corp | ANDA | Current |
| 43063-467 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-467 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-467 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-467 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-467 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-467 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-566 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-436 | Diclofenac Sodium | Diclofenac Sodium | Medsource pharmaceuticals | ANDA | Current |
| 50090-0538 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0539 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0539 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1769 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1769 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1769 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1769 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 51655-308 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | Northwind Pharmaceuticals | ANDA | Current |
| 53002-5361 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-150 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55700-127 | Diclofenac Sodium | Diclofenac Sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60429-421 | Diclofenac Sodium | Diclofenac Sodium | GSMS, Incorporated | ANDA | Current |
| 60429-421 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply | ANDA | Current |
| 60429-421 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-421 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-421 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-422 | Diclofenac Sodium | Diclofenac Sodium | GSMS, Incorporated | ANDA | Current |
| 60429-422 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply | ANDA | Current |
| 60429-422 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-422 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-422 | Diclofenac Sodium | Diclofenac Sodium | Golden State Medical Supply, Inc. | ANDA | Current |
| 63187-522 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63187-522 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63187-522 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63187-761 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63187-761 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63629-6947 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-6947 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63739-800 | Diclofenac Sodium | Diclofenac Sodium | McKesson Corporation | ANDA | Current |
| 63739-800 | Diclofenac Sodium | Diclofenac Sodium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 66267-358 | Diclofenac Sodium | Diclofenac Sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-358 | Diclofenac Sodium | Diclofenac Sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66336-238 | Diclofenac Sodium | Diclofenac Sodium | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-1225 | Diclofenac Sodium | Diclofenac Sodium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1225 | Diclofenac Sodium | Diclofenac Sodium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1225 | Diclofenac Sodium | Diclofenac Sodium | RedPharm Drug, Inc. | ANDA | Current |
| 67544-840 | Diclofenac Sodium | Diclofenac Sodium | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 67544-899 | Diclofenac Sodium | Diclofenac Sodium | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 68071-2045 | Diclofenac Sodium | Diclofenac Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2045 | Diclofenac Sodium | Diclofenac Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69176-010 | Inflammation Reduction Pack | Inflammation Reduction Pack | TMIG, Inc. | ANDA | Current |
| 69176-010 | Inflammation Reduction Pack | Inflammation Reduction Pack | TMIG, Inc. | ANDA | Current |
| 69176-010 | Inflammation Reduction Pack | Inflammation Reduction Pack | TMIG, Inc. | ANDA | Current |
| 69329-310 | DeramsilkRx Anodynexa Pak | diclofenac sodium delayed release tablets, ranitidine tablets, capsaicin cream | Patchwerx Labs, Inc. | ANDA | Current |
| 69329-330 | DermasilkRx DicloPak | diclofenac sodium delayed release tablets, ranitidine tablets, capsaicin cream | Patchwerx Labs, Inc. | ANDA | Current |