Application 020947
- Type
- NDA
- Sponsor
- NUVO PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENNSAID | DICLOFENAC SODIUM | SOLUTION;TOPICAL | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020947-001 | PENNSAID | DICLOFENAC SODIUM | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | |
| N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | |
| N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | |
| N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | |
| N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | b8a1b40f171c… |
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 | A-S Medication Solutions | d9698809-4887-4514-aa28-0066355ef908 | 2026-09-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | NuCare Pharmaceuticals, Inc. | 5a852412-69af-6502-e063-6294a90a0748 | 2026-09-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac | DICLOFENAC SODIUM | YYBA CORP | 533653e8-93d5-9080-e063-6394a90a165b | 2026-09-01 | Warnings | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Northwind Health Company, LLC | 5990259d-2f90-20d3-e063-6394a90a3d23 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| AMAZON BASIC CARE ARTHRITIS PAIN | DICLOFENAC SODIUM | Amazon.com Services LLC | 113e2f87-c408-3e44-e063-6394a90a0a7f | 2026-08-20 | Warnings | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Northwind Health Company, LLC | 4dde6e36-7540-1cc3-e063-6294a90a3941 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sportpharm LLC | e9ec5462-939a-4022-8946-5d81869a6277 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 2a7019e9-e20f-4897-9b8e-942a7f2b34f6 | 2026-08-12 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 226da8a2-807d-4784-8d33-b434f3951a52 | 2026-08-12 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 681b6b25-4a28-44f2-8042-d5e01a502116 | 2026-08-12 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 26282 | SUPPL | 2016-05-11 |
| 13807 | SUPPL | 2016-05-11 |
| 13806 | SUPPL | 2016-05-11 |
| 3835 | SUPPL | 2016-05-11 |
| 26281 | SUPPL | 2013-10-24 |
| 35704 | SUPPL | 2013-10-21 |
| 26280 | SUPPL | 2011-07-18 |
| 24184 | ORIG | 2010-05-06 |
| 21297 | ORIG | 2010-05-06 |
| 35703 | SUPPL | 2010-04-04 |
| 13805 | SUPPL | 2010-04-04 |
| 26279 | SUPPL | 2010-03-31 |
| 3834 | SUPPL | 2010-03-31 |
| 43687 | ORIG | 2009-11-18 |
| 26278 | ORIG | 2009-11-13 |
| 13804 | ORIG | 2009-11-12 |