Application 074432
- Type
- ANDA
- Sponsor
- PLIVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG | No | No |
| 003 | 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 |
|---|---|---|---|---|---|---|---|
| A074432-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | ||
| A074432-003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074432-002 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074432-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | 1999-07-29 | 74a2ff9319b5… |
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 | Preferred Pharmaceuticals Inc. | ed1b5ec7-2812-4a81-90d1-953baa0b0ec8 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Aurolife Pharma LLC | dfb7afdf-5c05-4487-9044-936e151e5ba6 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 5d0a4b41-afbf-45e7-bb1c-587d72314ee0 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 15b280a1-4964-4636-833b-3db44044d289 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC | Preferred Pharmaceuticals Inc. | 937e9ba5-cdad-4e72-a77a-bad699e1b236 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals, Inc. | 4a3549e0-1e2d-42bf-b82c-1e62837ba2e4 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | e042e64c-5f18-4483-bcbd-dfd9b08a81cf | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium 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 | Diclofenac Sodium |
| arthritis pain relieving | DICLOFENAC SODIUM | Walgreen Company | 0da5d1d0-d8a4-4509-a098-e9c36d282474 | 2026-03-31 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | REMEDYREPACK INC. | d349d286-b462-4f8f-aa39-6173653175d6 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium 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 | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 663a3dbc-a631-4046-8852-ec619c41c81d | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | DirectRx | d5f215d4-9aa3-2ecf-e053-2995a90a2e89 | 2026-03-17 | Warnings, Adverse reactions | DICLOFENAC SODIUM DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Direct_Rx | 946b3799-2d56-12a5-e053-2a95a90aeba0 | 2026-03-16 | Warnings, Adverse reactions | DICLOFENAC SODIUM DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Redpharm Drug | 4cd2e51b-2019-6eb6-e063-6294a90ad7ef | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Edenbridge Pharmaceuticals LLC. | bd25a2b1-a4d5-4893-97d1-efdcd414a97d | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 337c2253-34c1-4611-88c9-d558507255a2 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sun Pharmaceutical Industries, Inc. | fae53d24-acf1-4250-888d-b8d965ffc3d3 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | 942b4a76-1029-4cd7-9def-531ed33f3053 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8413 | ORIG | 1999-07-29 |