Application 207059
- Type
- ANDA
- Sponsor
- USPHARMA
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 |
|---|---|---|---|---|---|---|---|
| A207059-001 | LIDOCAINE | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2026-02-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207059-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207059-001 | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2026-02-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207059-001 | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2026-02-09 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A207059-001 | LIDOCAINE | 5% | PATCH / TOPICAL | AB | 2026-02-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207059-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207059-001 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A207059-001 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Gembooxt Topical Numbing Cream | LIDOCAINE | Guangdong Quadrant Ecological Technology Co., Ltd. | 49951a3e-3b62-3d66-e063-6294a90a9360 | 2026-08-12 | Warnings | LIDOCAINE |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 | 2026-08-12 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | Sentiss Pharmaceuticals LLC | 9b2d4f69-0c84-4956-b5c0-b4410acf62e0 | 2026-08-12 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | 864e511b-cc50-4ed9-b122-8e1a93457332 | 2026-08-11 | Warnings, Adverse reactions | Lidocaine |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-11 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | The Atlanta Dental Supply Company DBA Advanced Dental Products | 55030c51-250b-4fc2-ba3c-ac38dab7cc8e | 2026-08-10 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | df130310-41db-45df-a214-9da01cf0bf41 | 2026-08-10 | Warnings, Adverse reactions | Lidocaine |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-06 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | Ascend Laboratories, LLC | 67a6bbbd-ab4b-414a-b85c-b7d8c0cfa9d2 | 2026-08-06 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | NDC, Inc. | 937e9341-e604-4ca7-98e1-fc7c659d82e9 | 2026-08-06 | Warnings, Adverse reactions | LIDOCAINE |
| Dealmed Burn | LIDOCAINE | Dealmed Medical Supplies, LLC. | 3b5f7ded-c275-4d7f-9fd4-539797d5507e | 2026-08-05 | Warnings | LIDOCAINE |
| Lidocaine Plantar Relief Roll-On | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 585ccb4b-3bff-39b9-e063-6294a90a0e18 | 2026-08-05 | Warnings | LIDOCAINE |
| Lidocaine Numbing Cream | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 5457b3d7-e6b6-34a7-e063-6394a90aa240 | 2026-08-03 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE | PHOENIX RX LLC | 57edfcb8-272c-8af4-e063-6294a90ae2e5 | 2026-07-31 | Warnings, Adverse reactions | Lidocaine LIDOCAINE |
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Benco Dental | c5cc87df-df3f-42b8-af84-5f2045d42084 | 2026-07-30 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Benco Dental | 9419ac39-9b26-4cca-a2d6-167205fede24 | 2026-07-28 | Warnings, Adverse reactions | Lidocaine |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Patterson Dental | 6506755f-c9f7-4286-9ba7-ac5d5745f5e4 | 2026-07-28 | Warnings, Adverse reactions | LIDOCAINE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Darby Dental Supply, LLC | 27e8fdfb-e923-4f99-aff7-8b9e50228151 | 2026-07-27 | Warnings, Adverse reactions | Lidocaine |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Darby Dental Supply, LLC | e5ed4c2a-e320-48cf-a2fd-61d48481c624 | 2026-07-27 | Warnings, Adverse reactions | Lidocaine |