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 |
|---|---|---|---|---|---|---|
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 0897cc86-c775-8821-e063-6394a90a6fcf | 2026-05-14 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Gel -Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 4bdec2ee-37ee-86ea-e063-6294a90a49fd | 2026-05-14 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 2d76dd9a-6291-ae75-e063-6394a90a30e6 | 2026-05-14 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 31a099c4-91d8-352a-e063-6394a90a035f | 2026-05-14 | Warnings | LIDOCAINE |
| Lidocaine Pain Relief Patch | LIDOCAINE | GERI-CARE PHARMACEUTICAL CORP | 51b7753b-8619-6ea9-e063-6294a90a4ea4 | 2026-05-13 | Warnings | LIDOCAINE |
| Stud 100 Male Genital Desensitizer | LIDOCAINE | Pound International Corp | d075656e-b13f-4a1d-bbb6-501e642698d5 | 2026-05-12 | Warnings | LIDOCAINE |
| BonicaEaseX Pain Relieving Lidocaine | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 7486fe89-a377-4a37-997d-e3bd16b891a7 | 2026-05-11 | Warnings | LIDOCAINE |
| Walmart Equate Aloe Sunburn Relief Cooling | LIDOCAINE | WAL-MART STORES INC. | 51540f6b-596f-bc47-e063-6294a90a46ae | 2026-05-08 | Warnings | LIDOCAINE |
| Lidocaine 4% Cream | LIDOCAINE | Medcore LLC | 111cb421-ba3b-4772-ab60-d31eb4183168 | 2026-05-07 | Warnings | LIDOCAINE |
| Lidocaine 5% Cream | LIDOCAINE | Medcore LLC | 15d02b42-bf8b-486a-a081-f6d17cc11ec7 | 2026-05-07 | Warnings | LIDOCAINE |
| Lidoxi | LIDOCAINE | T&T Pharma Holdings LLC | 513c517e-c098-02aa-e063-6294a90ac8a4 | 2026-05-07 | Warnings | LIDOCAINE |
| TheraCare Flexible Pain Relieving | LIDOCAINE | Veridian Healthcare | 4f108002-2cae-0671-e063-6294a90ab6cf | 2026-04-30 | Warnings | LIDOCAINE |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | 0578fbcb-875a-4606-acde-dcecb29756e6 | 2026-04-30 | Warnings | LIDOCAINE |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | 32ab24b4-dcec-4a09-e054-00144ff88e88 | 2026-04-30 | Warnings | LIDOCAINE |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | c2c0cb17-401a-4ba2-aa04-64c9b43cd21b | 2026-04-30 | Warnings | LIDOCAINE |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | e840fba4-86ff-9da0-e053-2995a90a221a | 2026-04-30 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Sportpharm LLC | cffda6fc-7e85-4c48-9623-2551d3552d7d | 2026-04-24 | Warnings, Adverse reactions | Lidocaine |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Henry Schein Inc. | 1ca96c77-d983-496b-84a6-54709e80f532 | 2026-04-23 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Henry Schein Inc. | f8d90500-f797-4238-8dd2-b59cbcd89d12 | 2026-04-23 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Sportpharm LLC | 7adb9ab0-ef91-4c51-baa3-a0b7e12df077 | 2026-04-21 | Warnings, Adverse reactions | 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 |