Application 078772
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.01MG/ML;2% | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.02MG/ML;2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | ||
| A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078772-001 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.01MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078772-002 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | 0.02MG/ML;2% | INJECTABLE / INJECTION | 2008-05-12 | f41ea6bd6efb… |
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 and Epinephrine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Cardinal Health 107, LLC | 77fd6ee4-108f-4525-8df5-7db9236042ee | 2026-05-20 | Warnings, Adverse reactions | Lidocaine Hydrochloride and Epinephrine |
| Lidocaine Hydrochloride and Epinephrine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein, Inc. | 5569d607-f1cb-4f1d-8a00-d50433ec05d3 | 2026-05-07 | Warnings, Adverse reactions | Lidocaine Hydrochloride and Epinephrine |
| Lidocaine Hydrochloride and Epinephrine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Sportpharm LLC | 2c58deba-dbb2-4e73-a173-36053536f03e | 2026-04-22 | Warnings, Adverse reactions | Lidocaine Hydrochloride and Epinephrine |
| Lidocaine Hydrochloride and Epinephrine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein, Inc. | c3490a23-14c4-43f7-b066-96a4c4298fde | 2026-04-14 | Warnings, Adverse reactions | Lidocaine Hydrochloride and Epinephrine |
| Lidocaine Hydrochloride and Epinephrine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | ProPharma Distribution | 43048b6b-3c83-eef4-e063-6294a90a34cb | 2025-12-18 | Warnings, Adverse reactions | Lidocaine Hydrochloride and Epinephrine |
| Lidocaine Hydrochloride and Epinephrine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Henry Schein, Inc. | e0e621d2-10b0-4cdf-b31d-c19b1e86ba6b | 2025-06-03 | Warnings, Adverse reactions | Lidocaine Hydrochloride and Epinephrine |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.