Application 080409
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LTA II KIT | LIDOCAINE HYDROCHLORIDE | SOLUTION;TOPICAL | 4% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080409-001 | LTA II KIT | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION / TOPICAL | Approved before 1982 |
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 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080409-001 | LTA II KIT | 4% | SOLUTION / TOPICAL | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Hello Sugar | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 5f30254d-a28f-443d-8729-5c5dde4a0217 | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| TattooNumb | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | d9c4d664-54de-40c2-8836-72b60e6d9ac0 | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| BeardedMoney | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | 35ff688b-75c5-4780-b294-192af780d705 | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| NeuroMed 7 Topical Pain Relief | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals, LLC | f199f56b-d971-4cf8-834d-babb5c2ff81a | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| NeuroMed Topical Anesthetic 7 | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals | 8a2b6b76-6bcc-4f52-b037-e6cbc74f8377 | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| NeuroMed Topical Anesthetic 7 | LIDOCAINE HYDROCHLORIDE | Sambria Pharmaceuticals | 67b25c37-db32-4980-88b0-b07712345939 | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidozall | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | 1eb2dfb2-3ad1-488b-aed9-17220e34a10c | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidozall Plus | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ba3cbb15-f4ed-443e-af43-a758481acb0b | 2025-11-12 | Warnings | LIDOCAINE HYDROCHLORIDE |
| TopCare Pain Relief Maximum Strength | LIDOCAINE HYDROCHLORIDE | TOPCO ASSOCIATES | b0ae3a7c-52d1-4923-bd50-6bb3749006c8 | 2025-11-11 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Eugia US LLC | 5524cbfd-d6e6-42eb-aaa5-22495e0a86b6 | 2025-11-11 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| GuruNanda Pain Relief | LIDOCAINE HYDROCHLORIDE | GuruNanda, LLC. | 3ab6a133-8dca-e14e-e063-6394a90a85e7 | 2025-11-10 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Xylocaine | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ffc87dfb-0e26-4b42-80fd-3fb7690119e3 | 2025-11-07 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | A-S Medication Solutions | e67dee40-b243-4d6b-bc6b-e52c6cb798b8 | 2025-11-01 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | f73d4546-c9ac-4155-8492-552d6ce70c84 | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | 23c8f711-e458-479a-9ab0-dcc851311e24 | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | f0617ab8-555f-4cbe-9795-c922f5ef176e | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ddaee8bc-f55c-48b1-9b0e-ad1e2dd15a2c | 2025-10-31 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Marlex Pharmaceuticals, Inc. | e1badbba-59af-e451-e053-2a95a90a49f8 | 2025-10-30 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC. | 42531a38-7cff-de16-e063-6394a90a18d8 | 2025-10-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine | LIDOCAINE HYDROCHLORIDE | A-S Medication Solutions | e6c83ad7-2821-432b-8610-0f54cfe610cb | 2025-10-21 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |