Application 217221
- Type
- ANDA
- Sponsor
- DIFGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE | LIDOCAINE | PATCH;TOPICAL | 1.8% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217221-001 | LIDOCAINE | LIDOCAINE | 1.8% | PATCH / TOPICAL | AB | 2025-03-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217221-001 | 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 | A217221-001 | LIDOCAINE | 1.8% | PATCH / TOPICAL | AB | 2025-03-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217221-001 | LIDOCAINE | 1.8% | PATCH / TOPICAL | AB | 2025-03-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217221-001 | LIDOCAINE | 1.8% | PATCH / TOPICAL | AB | 2025-03-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217221-001 | LIDOCAINE | 1.8% | PATCH / TOPICAL | AB | 2025-03-25 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217221-001 | LIDOCAINE | 1.8% | PATCH / TOPICAL | AB | 2025-03-25 | 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 | A217221-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217221-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217221-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217221-001 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217221-001 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |