Application 202769
- Type
- ANDA
- Sponsor
- TELIGENT PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | SOLUTION;TOPICAL | 1.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202769-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 |
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 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | 2015-07-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202769-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-07-08 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202769-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202769-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202769-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202769-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202769-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202769-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202769-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202769-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202769-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202769-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202769-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202769-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202769-001 | AT | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202769-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202769-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A202769-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A202769-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202769-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A202769-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A202769-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202769-001 | AT | 1 | cb3db0bc1861… |
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 | Quality Care Products LLC | 94422b85-28ed-477f-853a-71d1d6cf17d5 | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | 202769 ANDA202769 55700-591 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 7bc185e2-e749-4a24-8550-c2f6d39222d2 | 2020-04-01 | Boxed warning, Warnings, Adverse reactions | 202769 ANDA202769 71205-450 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45865-964 | Diclofenac Sodium | Diclofenac Sodium | medsource pharmaceuticals | ANDA | Current |
| 50090-4018 | Diclofenac Sodium | diclofenac sodium | A-S Medication Solutions | ANDA | Current |
| 50436-2225 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical | Unit Dose Services | ANDA | Current |
| 51021-150 | Diclofenac Sodium | Diclofenac Sodium | Sircle Laboratories, LLC | ANDA | Current |
| 52565-002 | Diclofenac Sodium | diclofenac sodium | Teligent Pharma, Inc. | ANDA | Current |
| 52565-002 | Diclofenac Sodium | diclofenac sodium | Teligent Pharma, Inc. | ANDA | Current |
| 55700-591 | Diclofenac Sodium | Diclofenac Sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-591 | Diclofenac Sodium | Diclofenac Sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-591 | Diclofenac Sodium | Diclofenac Sodium | Quality Care Products LLC | ANDA | Current |
| 55700-878 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Quality Care Products, LLC | ANDA | Current |
| 59088-343 | DermacinRx Lexitral PharmaPak | diclofenac sodium, capsaicin | PureTek Corporation | ANDA | Current |
| 59088-343 | DermacinRx Lexitral PharmaPak | diclofenac sodium, capsaicin | PureTek Corporation | ANDA | Current |
| 59088-365 | Xrylix | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-365 | Xrylix | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-372 | Diclofenac Sodium | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-372 | Diclofenac Sodium | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-372 | Diclofenac Sodium | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-372 | Diclofenac Sodium | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-372 | Diclofenac Sodium | Diclofenac Sodium | PureTek Corporation | ANDA | Current |
| 59088-704 | Leximenth | diclofenac sodium, lidocaine, menthol | PureTek Corporation | ANDA | Current |
| 59088-704 | Leximenth | diclofenac sodium, lidocaine, menthol | PureTek Corporation | ANDA | Current |
| 59088-716 | Diclotrex | diclofenac sodium, camphor, menthol | PureTek Corporation | ANDA | Current |
| 59088-716 | Diclotrex | diclofenac sodium, camphor, menthol | PureTek Corporation | ANDA | Current |
| 60760-112 | Diclofenac Sodium | Diclofenac Sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-675 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | DIRECT RX | ANDA | Current |
| 61919-675 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | DIRECT RX | ANDA | Current |
| 63187-677 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 68788-6368 | Diclofenac Sodium | Diclofenac Sodium | Preferred Pharmcacuticals Inc. | ANDA | Current |
| 68788-7701 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7701 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69621-343 | Xelitral | diclofenac sodium, capsaicin | Shoreline Pharmaceuticals | ANDA | Current |
| 69621-365 | Lexixryl | Diclofenac Sodium | Shoreline Pharmaceuticals, Inc. | ANDA | Current |
| 69621-707 | TriXylitral | Diclofenac Sodium, Lidocaine Hydrochloride | Shoreline Pharmaceuticals | ANDA | Current |
| 70512-025 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | KBS Solutions LLC | ANDA | Current |
| 70512-025 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | KBS Solutions LLC | ANDA | Current |
| 70512-025 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | SOLA Pharmaceuticals | ANDA | Current |
| 70512-025 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | KBS Solutions LLC | ANDA | Current |
| 70512-025 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Sola Pharmaceuticals | ANDA | Current |
| 70518-2944 | Diclofenac Sodium | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2944 | Diclofenac Sodium | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2944 | Diclofenac Sodium | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2944 | Diclofenac Sodium | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 70859-003 | NuDiclo SoluPak | diclofenac sodium, capsaicin | Nucare Pharmaceuticals Inc | ANDA | Current |
| 70859-003 | NuDiclo SoluPak | diclofenac sodium, capsaicin | Nucare Pharmaceuticals Inc | ANDA | Current |
| 70859-003 | NuDiclo SoluPak | diclofenac sodium, capsaicin | Nucare Pharmaceuticals Inc | ANDA | Current |
| 70859-045 | DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAK | diclofenac sodium, Methyl Salicylate/Menthol/Capsaicin | Nucare Pharmaceuticals Inc | ANDA | Current |
| 70859-045 | DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAK | diclofenac sodium, Methyl Salicylate/Menthol/Capsaicin | Nucare Pharmaceuticals Inc | ANDA | Current |
| 71205-138 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Proficient Rx LP | ANDA | Current |
| 71205-138 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Proficient Rx LP | ANDA | Current |
| 71205-138 | Diclofenac Sodium 1.5% | Diclofenac Sodium Topical Solution | Proficient Rx LP | ANDA | Current |
| 71205-450 | Diclofenac Sodium | diclofenac sodium | Proficient Rx LP | ANDA | Current |
| 72275-702 | Diclovix | diclofenac sodium, with camphor, lidocaine, and methyl salicylate patch | Primary Pharmaceuticals, Inc | ANDA | Current |
| 72275-719 | Diclovix M | diclofenac sodium, with camphor, lidocaine, and methyl salicylate patch | Primary Pharmaceuticals, Inc | ANDA | Current |
| 72275-734 | Diclovix CM | diclofenac sodium, with capsaicin cream and camphor, lidocaine, and methyl salicylate patch | Primary Pharmaceuticals, Inc | ANDA | Current |
| 72275-746 | Pennsaicin | Diclofenac Sodium Topical with Capsaicin Cream | Primary Pharmaceuticals, Inc | ANDA | Current |
| 72275-746 | Pennsaicin | Diclofenac Sodium Topical with Capsaicin Cream | Primary Pharmaceuticals, Inc | ANDA | Current |
| 81877-502 | DicloHeal-60 | diclofenac sodium, capsaicin | Forreal Pharmaceuticals LLC | ANDA | Current |
| 81877-502 | DicloHeal-60 | diclofenac sodium, capsaicin | Forreal Pharmaceuticals LLC | ANDA | Current |
| 81877-502 | DicloHeal-60 | diclofenac sodium, capsaicin | Forreal Pharmaceuticals LLC | ANDA | Current |