Application 203265
- Type
- ANDA
- Sponsor
- NOVEN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE | LIDOCAINE | PATCH;TOPICAL | 5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203265-001 | LIDOCAINE | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 |
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 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2020-12-01 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2020-12-01 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2020-12-01 | 8869cabd3fbd… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203265-001 | LIDOCAINE | 5% | PATCH / TOPICAL | 2020-12-01 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203265-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203265-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203265-001 | AB | 1 | 8869cabd3fbd… |
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 |
|---|---|---|---|---|---|---|
| MyDerm Aloe and Lidocaine | LIDOCAINE | Inspec Solutions LLC. | 4939c663-a876-4527-822a-df02964fa694 | 2026-05-26 | Warnings | LIDOCAINE |
| lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | 54df7353-5411-43ad-bd7b-a3d4d62c72c6 | 2026-05-21 | Warnings, Adverse reactions | lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | 4806f94d-cbac-4107-b93b-8f715868ffb3 | 2026-05-21 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | ebc05cf9-e82b-4f7d-b5e7-3e62025ce68c | 2026-05-21 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine | LIDOCAINE | Preferred Pharmaceuticals Inc. | 323e0ec2-c2e5-47d1-a39f-69ff5c99e324 | 2026-05-21 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Lidocaine Pain Relief Patch | LIDOCAINE | GERI-CARE PHARMACEUTICAL CORP | 522f1521-f9f2-4c26-e063-6394a90a9e05 | 2026-05-19 | Warnings | LIDOCAINE |
| Burn Relief | LIDOCAINE | WALMART INC. | 15af4557-4baf-c177-e063-6294a90a7a5b | 2026-05-18 | Warnings | LIDOCAINE |
| LIDOCAINE PAIN RELIEF Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 01ff3442-5a4e-4013-e063-6294a90a809e | 2026-05-17 | Warnings | LIDOCAINE |
| LIDOCAINE PAIN RELIEF Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 247ecba5-196b-0179-e063-6394a90a0371 | 2026-05-17 | Warnings | LIDOCAINE |
| LIDOCAINE PAIN RELIEF Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 322aa97d-b35b-d9dd-e063-6394a90a7ae5 | 2026-05-17 | Warnings | LIDOCAINE |
| KY Duration for Him | LIDOCAINE | Reckitt Benckiser LLC | 83cc86bd-3303-4956-a198-fae85b6e34e1 | 2026-05-15 | Warnings | LIDOCAINE |
| Lidocaine Knee Pain Relief Patch | LIDOCAINE | Guangzhou Sumi Technology Innovation Co., Ltd | 4fdbc841-ee84-c1b3-e063-6294a90a6f5c | 2026-05-14 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Gel -Patch | LIDOCAINE | Guangzhou Sumi Technology Innovation Co., Ltd | 514900f1-7fcb-636a-e063-6394a90a4ba2 | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relief Gel-Roll On | LIDOCAINE | Trifecta Pharmaceuticals USA | 51cb6797-55ec-7a7a-e063-6294a90a90ee | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relieving Gel-Patch | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 412fd7c8-1e05-1779-e063-6294a90a3de4 | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relief | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 433ac435-279e-574b-e063-6294a90a1d6d | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relief | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 3ef5bfac-0c05-b703-e063-6394a90a2276 | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relieving Gel-Patch | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 3737cd00-0582-94e6-e063-6394a90a6280 | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relieving Gel-Patch | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f1045448-ae78-eba6-e053-2a95a90a6793 | 2026-05-14 | Warnings | LIDOCAINE |
| Pain Relieving Gel-Patch | LIDOCAINE | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | fd0d4646-4b5e-3fe8-e053-6394a90ad6c4 | 2026-05-14 | Warnings | LIDOCAINE |
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 |
|---|---|---|---|---|---|
| 66993-342 | Lidocaine Patch, 5% | Lidocaine | Prasco Laboratories | ANDA | Current |