Application 020607
- Type
- NDA
- Sponsor
- GD SEARLE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | TABLET, DELAYED RELEASE;ORAL | 50MG;0.2MG | Yes | No |
| 002 | ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | TABLET, DELAYED RELEASE;ORAL | 75MG;0.2MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020607-001 | ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 |
| N020607-002 | ARTHROTEC | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020607-001 | AB |
| N020607-002 | 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 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020607-001 | ARTHROTEC | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 1997-12-24 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020607-002 | ARTHROTEC | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 1997-12-24 | 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 | N020607-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020607-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020607-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020607-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020607-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020607-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020607-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020607-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020607-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020607-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020607-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020607-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020607-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020607-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020607-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020607-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020607-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020607-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020607-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020607-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020607-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020607-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020607-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020607-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020607-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020607-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020607-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N020607-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020607-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020607-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020607-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020607-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020607-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020607-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020607-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020607-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020607-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020607-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020607-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020607-002 | 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 and Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Mylan Pharmaceuticals Inc. | a7701e8c-4e16-4165-8b83-de2c08d5ded3 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 020607 NDA020607 59762-0028 59762-0029 |
| ARTHROTEC | DICLOFENAC SODIUM AND MISOPROSTOL | Pfizer Laboratories Div Pfizer Inc | 600fe842-45d9-4d68-9ef2-456dbbebaa11 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | 020607 NDA020607 0025-1411 0025-1421 |
| Diclofenac sodium and Misoprostol DR | DICLOFENAC SODIUM AND MISOPROSTOL | Advanced Rx Pharmacy of Tennessee, LLC | 1213d3eb-9870-f144-e063-6394a90a6088 | 2024-02-23 | Boxed warning, Warnings, Adverse reactions | 020607 NDA020607 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1411 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | G.D. Searle LLC Division of Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0025-1421 | ARTHROTEC | diclofenac sodium and misoprostol | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 21695-425 | ARTHROTEC | diclofenac sodium and misoprostol | Rebel Distributors Corp. | NDA | Current |
| 49999-987 | ARTHROTEC | diclofenac sodium and misoprostol | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | NDA | Current |
| 55289-406 | ARTHROTEC | diclofenac sodium and misoprostol | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0028 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0029 | Diclofenac sodium and Misoprostol | Diclofenac sodium and Misoprostol | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80410 | SUPPL | 2024-11-25 |
| 80409 | SUPPL | 2024-11-25 |
| 80280 | SUPPL | 2024-11-22 |
| 73041 | SUPPL | 2022-12-27 |
| 73021 | SUPPL | 2022-12-23 |
| 71969 | SUPPL | 2022-08-30 |
| 71968 | SUPPL | 2022-08-30 |
| 71938 | SUPPL | 2022-08-29 |
| 68292 | SUPPL | 2021-08-05 |
| 68274 | SUPPL | 2021-08-03 |
| 67400 | SUPPL | 2021-05-04 |
| 67255 | SUPPL | 2021-04-29 |
| 64685 | SUPPL | 2020-09-25 |
| 64683 | SUPPL | 2020-09-25 |
| 64677 | SUPPL | 2020-09-25 |
| 64144 | SUPPL | 2020-07-30 |
| 64143 | SUPPL | 2020-07-30 |
| 64120 | SUPPL | 2020-07-29 |
| 25316 | SUPPL | 2016-05-12 |
| 12841 | SUPPL | 2016-05-11 |
| 25315 | SUPPL | 2015-04-03 |
| 34952 | SUPPL | 2015-04-02 |
| 12840 | SUPPL | 2014-09-09 |
| 2868 | SUPPL | 2014-09-05 |
| 34953 | SUPPL | 2013-03-08 |
| 2867 | SUPPL | 2013-03-08 |
| 34951 | SUPPL | 2010-12-22 |
| 25314 | SUPPL | 2010-12-22 |
| 2866 | SUPPL | 2009-11-10 |
| 23167 | ORIG | 2009-10-30 |
| 12839 | SUPPL | 2009-10-06 |
| 34950 | SUPPL | 2009-03-17 |
| 25313 | SUPPL | 2009-02-27 |
| 25312 | SUPPL | 2007-08-27 |
| 12838 | SUPPL | 2007-08-27 |
| 2865 | SUPPL | 2006-01-30 |
| 12837 | SUPPL | 2006-01-25 |
| 2864 | SUPPL | 2005-07-15 |
| 41478 | ORIG | 2003-08-08 |
| 41479 | SUPPL | 1999-02-22 |