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 |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Cardinal Health 107, LLC | 32513e8b-2a81-436e-8da2-439c1dcbf116 | 2025-10-20 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Ear Pain MD | LIDOCAINE HYDROCHLORIDE | Eosera Inc | 78c4418f-7f0f-447f-a94f-d4c89a081af1 | 2025-10-17 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Trilocaine | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | c58257bf-f06b-48d1-92df-a680dbd5eea0 | 2025-10-15 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Trilogel | LIDOCAINE HYDROCHLORIDE | Trifluent Pharma LLC | 22af7d63-6a56-4a38-a95b-0f88410b23cb | 2025-10-14 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | The J. Molner Company LLC | 17880468-873f-6465-e063-6294a90a9c73 | 2025-10-06 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 40339593-1142-53ef-e063-6394a90afd4f | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Atlantic Biologicals Corp. | 401ecb6c-392b-1d74-e063-6294a90a4005 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Henry Schein, Inc. | ee21518e-b3ed-405a-ac3b-bfe753893dba | 2025-09-29 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | REMEDYREPACK INC. | f824b48c-7039-4ce1-b3df-b3597aba5beb | 2025-09-26 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| Medi-First Burn | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 44bb5f25-1114-4bb1-8bcf-40402594abc4 | 2025-09-09 | Warnings | LIDOCAINE HYDROCHLORIDE |
| MediFirst Burn | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9fa5b348-29c2-4cd0-a945-0486bd27f5e0 | 2025-09-08 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Unifirst First Aid Corporation | 4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8 | 2025-09-08 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | American Health Packaging | 0a36a6de-40d5-41ba-bb5f-39d36c267b7f | 2025-09-02 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| HealthWise 4% Lidocaine Cream 2.7 oz | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | f39eb3d0-e153-4f50-85b1-ad5c677d176c | 2025-08-28 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Cintas First Aid & Safety | 96f17095-31f3-4b8a-ab22-0caaefaa7476 | 2025-08-15 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Aruba Aloe Alcoholada | LIDOCAINE HYDROCHLORIDE | Aruba Aloe Balm NV | f56c62b0-75db-4499-858e-54e10b0e140a | 2025-08-07 | Warnings | LIDOCAINE HYDROCHLORIDE |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Lannett Company, Inc. | c3353e08-2a8c-4ace-ba89-114f7131b8de | 2025-08-07 | Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | Aurobindo Pharma Limited | ab461805-413a-4fb3-88a1-224e1c423084 | 2025-07-30 | Boxed warning, Warnings, Adverse reactions | LIDOCAINE HYDROCHLORIDE |
| QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On | LIDOCAINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4 | 2025-07-11 | Warnings | LIDOCAINE HYDROCHLORIDE |