Application 088390
- Type
- ANDA
- Sponsor
- DEPROCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIGNOSPAN STANDARD | EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 0.01MG BASE/ML;2% | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088390-001 | LIGNOSPAN STANDARD | EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 |
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 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RS | 1985-01-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088390-001 | LIGNOSPAN STANDARD | EQ 0.01MG BASE/ML;2% | INJECTABLE / INJECTION | RLD, RS | 1985-01-22 | 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 | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Benco Dental | c5cc87df-df3f-42b8-af84-5f2045d42084 | 2026-07-30 | Warnings, Adverse reactions | 088390 ANDA088390 66975-425 |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Patterson Dental | 6506755f-c9f7-4286-9ba7-ac5d5745f5e4 | 2026-07-28 | Warnings, Adverse reactions | 088390 ANDA088390 50227-1030 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Darby Dental Supply, LLC | e5ed4c2a-e320-48cf-a2fd-61d48481c624 | 2026-07-27 | Warnings, Adverse reactions | 088390 ANDA088390 66467-9730 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Henry Schein Inc. | f8d90500-f797-4238-8dd2-b59cbcd89d12 | 2026-04-23 | Warnings, Adverse reactions | 088390 ANDA088390 0404-6512 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Novocol Pharmaceutical of Canada, Inc. | 2005680a-8a23-4403-a618-e4ee74fa1121 | 2026-03-26 | Warnings, Adverse reactions | 088390 ANDA088390 |
| Lignospan Standard | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | f902d2b4-28fc-41b1-a9f7-0d1a63c598aa | 2025-03-20 | Warnings, Adverse reactions | 088390 ANDA088390 0362-1095 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Safco Dental Supply Co | 6721c3ab-c37f-4504-aebc-0103c56ed567 | 2024-02-08 | Warnings, Adverse reactions | 088390 ANDA088390 67239-0240 |
| LIDOCAINE | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | NDC, Inc. | 937e9341-e604-4ca7-98e1-fc7c659d82e9 | 2024-02-08 | Warnings, Adverse reactions | 088390 ANDA088390 43128-105 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | The Atlanta Dental Supply Company DBA Advanced Dental Products | 55030c51-250b-4fc2-ba3c-ac38dab7cc8e | 2024-02-08 | Warnings, Adverse reactions | 088390 ANDA088390 71347-210 |
| Lidocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | Septodont, Inc. | 864e511b-cc50-4ed9-b122-8e1a93457332 | 2024-02-08 | Warnings, Adverse reactions | 088390 ANDA088390 0362-0898 |
| Xylocaine | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | Dentsply Pharmaceutical | 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1 | 2024-02-05 | Warnings, Adverse reactions | 088390 ANDA088390 66312-176 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0362-0898 | Lidocaine | Lidocaine Hydrochloride and Epinephrine | Septodont, Inc. | ANDA | Current |
| 0362-0898 | Lidocaine | Lidocaine Hydrochloride and Epinephrine | Septodont, Inc. | ANDA | Current |
| 0362-1095 | Lignospan Standard | Lidocaine Hydrochloride and Epinephrine | Septodont, Inc. | ANDA | Current |
| 0362-1095 | Lignospan Standard | Lidocaine Hydrochloride and Epinephrine | Septodont, Inc. | ANDA | Current |
| 0362-1095 | Lignospan Standard | Lidocaine Hydrochloride and Epinephrine | Septodont, Inc. | ANDA | Current |
| 0362-1095 | Lignospan Standard | Lidocaine Hydrochloride and Epinephrine | Septodont, Inc. | ANDA | Current |
| 0362-9023 | Octocaine 100 | Lidocaine Hydrochloride and Epinephrine Bitartrate | Septodont | ANDA | Current |
| 0404-6512 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Henry Schein Inc. | ANDA | Current |
| 0404-6512 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Henry Schein Inc. | ANDA | Current |
| 0404-6512 | LIDOCAINE | Lidocaine Hydrochloride and Epinephrine Bitartrate | Henry Schein | ANDA | Current |
| 0404-6512 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Henry Scein Inc | ANDA | Current |
| 0404-6512 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Henry Scein Inc | ANDA | Current |
| 0404-6512 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Henry Schein Inc. | ANDA | Current |
| 31382-898 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | CareStream Health, Inc. | ANDA | Current |
| 42756-1030 | Lidocaine Hydrochloride and Epinephrine Bitartrate | Lidocaine Hydrochloride and Epinephrine Bitartrate | IQ Dental | ANDA | Current |
| 42756-1030 | Lidocaine Hydrochloride and Epinephrine Bitartrate | Lidocaine Hydrochloride and Epinephrine Bitartrate | IQ Dental | ANDA | Current |
| 43128-105 | LIDOCAINE | Lidocaine Hydrochloride and Epinephrine Bitartrate | NDC, Inc. | ANDA | Current |
| 43128-105 | LIDOCAINE | Lidocaine Hydrochloride and Epinephrine Bitartrate | NDC, Inc. | ANDA | Current |
| 43305-1030 | LIDOCAINE HCl | Lidocaine Hydrochloride and Epinephrine Bitartrate | Pearson Dental | ANDA | Current |
| 50227-1030 | LIDOCAINE | Lidocaine Hydrochloride and Epinephrine Bitartrate | Patterson Dental | ANDA | Current |
| 50227-1030 | LIDOCAINE | Lidocaine Hydrochloride and Epinephrine Bitartrate | Patterson Dental | ANDA | Current |
| 51004-1051 | LIDOCAINE | Lidocaine Hydrochloride and Epinephrine Bitartrate | Novocol Pharmaceutical of Canada, Inc. | ANDA | Current |
| 51004-1095 | Lignospan Standard | Lidocaine Hydrochloride and Epinephrine Bitartrate | Novocol Pharmaceutical of Canada, Inc. | ANDA | Current |
| 51004-2010 | Lidocaine Hydrochloride and Epinephrine Bitartrate | Lidocaine Hydrochloride and Epinephrine Bitartrate | Novocol Pharmaceutical of Canada, Inc. | ANDA | Current |
| 66312-176 | Xylocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | ANDA | Current |
| 66312-176 | Xylocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | ANDA | Current |
| 66312-176 | Xylocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Dentsply Pharmaceutical | ANDA | Current |
| 66467-9730 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Darby Dental Supply, LLC | ANDA | Current |
| 66467-9730 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Darby Dental Supply, LLC | ANDA | Current |
| 66975-425 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Benco Dental | ANDA | Current |
| 66975-425 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Benco Dental | ANDA | Current |
| 67239-0240 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Safco Dental Supply Co | ANDA | Current |
| 67239-0240 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | Safco Dental Supply Co | ANDA | Current |
| 71347-210 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | The Atlanta Dental Supply Company DBA Advanced Dental Products | ANDA | Current |
| 71347-210 | Lidocaine | Lidocaine Hydrochloride and Epinephrine Bitartrate | The Atlanta Dental Supply Company DBA Advanced Dental Products | ANDA | Current |