Application 075185
- Type
- ANDA
- Sponsor
- CARLSBAD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG | No | No |
| 002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG | No | No |
| 003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075185-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075185-001 | AB |
| A075185-002 | AB |
| A075185-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075185-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075185-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075185-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075185-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | AB | 1 | 301d65b070ca… |
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 Delayed Release | DICLOFENAC SODIUM | PHOENIX RX LLC | 41472cca-278b-934b-e063-6294a90aaf5d | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Golden State Medical Supply, Inc. | 39e67a90-df3e-ad30-e063-6394a90a7a82 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Carlsbad Technology, Inc. | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 2025-06-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 61442-101 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Carlsbad Technology, Inc. | 40879600-ba6c-43a8-aa5d-d0d41503d593 | 2025-05-28 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 61442-103 61442-102 |
| Diclofenac Sodium | DICLOFENAC SODIUM | RedPharm Drug, Inc. | 4ecb7bdc-4a5e-7444-e054-00144ff88e88 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | c933eaad-ba53-4130-90db-a66f89dfc29f | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 5b4c1a15-ed93-7192-e053-2991aa0a8360 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | d424ab84-2aaa-38a9-e053-2a95a90adde9 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | ec06cca5-3436-10c8-e053-2995a90a4aeb | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | af8a1392-67e8-8201-e053-2a95a90a0fce | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Inflammacin | DICLOFENAC SODIUM, CAPSAICIN | PureTek Corporation | 91d25301-fac9-41f0-8a4e-e22d44926347 | 2024-12-03 | Boxed warning, Warnings, Adverse reactions | 59088-093 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | ae0add8e-3a8a-4c5d-af3b-907f64211fef | 2024-10-30 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 70156824-e5dd-42b1-9b4f-a49acb28d316 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 50090-0542 50090-0545 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 2bebda5e-227e-4a49-80e3-191cfc805295 | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 63629-2010 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 12cce748-a7de-4b1e-9603-b5c2ce12d531 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 2b7462e6-62dc-4b08-9fbf-5858e356a7a8 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 63629-2077 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals, Inc. | 4b44ac98-225c-1739-e054-00144ff88e88 | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 8bda6135-c957-6b4e-e053-2995a90a0cb5 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 629b77cf-f825-8640-e053-2991aa0a10a8 | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Bryant Ranch Prepack | 7bf19e84-4f75-4d5c-9927-99220c58b572 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-6396 | Diclofenac Sodium | Diclofenac Sodium | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 10544-188 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-189 | Diclofenac Sodium | Diclofenac Sodium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 42254-059 | Diclofenac Sodium | Diclofenac Sodium | Rebel Distributors Corp | ANDA | Current |
| 42291-230 | Diclofenac Sodium | Diclofenac Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-230 | Diclofenac Sodium | Diclofenac Sodium | AvKARE | ANDA | Current |
| 42291-231 | Diclofenac Sodium | Diclofenac Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-231 | Diclofenac Sodium | Diclofenac Sodium | AvKARE | ANDA | Current |
| 43063-693 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-694 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-784 | Diclofenac Sodium | Diclofenac Sodium | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 45865-999 | Diclofenac Sodium | Diclofenac Sodium | medsource pharmaceuticals | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0542 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0543 | Diclofenac Sodium Delayed Release | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0543 | Diclofenac Sodium Delayed Release | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-0545 | Diclofenac Sodium | Diclofenac Sodium | A-S Medication Solutions | ANDA | Current |
| 50436-1003 | Diclofenac Sodium | Diclofenac Sodium | Unit Dose Services | ANDA | Current |
| 50436-1022 | Diclofenac Sodium | Diclofenac Sodium | Unit Dose Services | ANDA | Current |
| 51655-176 | Diclofenac Sodium | Diclofenac Sodium | NORTHWIND PHARMACEUTICALS | ANDA | Current |
| 53002-5360 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5360 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5370 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5370 | Diclofenac Sodium | Diclofenac Sodium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-834 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-834 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products, LLC | ANDA | Current |
| 55700-834 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products, LLC | ANDA | Current |
| 59088-093 | Inflammacin | diclofenac sodium, capsaicin | PureTek Corporation | ANDA | Current |
| 59088-093 | Inflammacin | diclofenac sodium, capsaicin | PureTek Corporation | ANDA | Current |
| 60760-153 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-154 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-154 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61145-101 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-101 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-101 | Diclofenac Sodium | Diclofenac Sodium | REPHARM LLC | ANDA | Current |
| 61145-102 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-102 | Diclofenac Sodium | Diclofenac Sodium | RePharm Pharmaceuticals | ANDA | Current |
| 61145-102 | Diclofenac Sodium | Diclofenac Sodium | REPHARM LLC | ANDA | Current |
| 61442-101 | Diclofenac Sodium | Diclofenac Sodium | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-102 | Diclofenac Sodium | Diclofenac Sodium | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-103 | Diclofenac Sodium | Diclofenac Sodium | Carlsbad Technology, Inc. | ANDA | Current |
| 61919-074 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-074 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-074 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct_Rx | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct_Rx | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 61919-075 | Diclofenac Sodium D/R | Diclofenac Sodium D/R | Direct RX | ANDA | Current |
| 63187-222 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63187-222 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63629-1011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-1534 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2010 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2010 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2011 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2012 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2013 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2013 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2077 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-2077 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7654 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7654 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7655 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-7655 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8555 | ORIG | 1998-11-13 |