Application 211096
- Type
- ANDA
- Sponsor
- NOVOCOL HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 0.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211096-001 | BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 |
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 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211096-001 | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE / INJECTION | 2019-02-19 | 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 |
|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | NorthStar RxLLC | ee3b5bbe-4013-4682-b6ee-db86e7788077 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE |
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 562f4499-f3b7-4d9e-b022-61172176c883 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE |
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c | 2026-06-24 | Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE |
| Marcaine | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | 67578b56-7540-487e-1fba-481255620e78 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Sportpharm LLC | 6f9ebeef-350a-495e-a0bf-c335ab48bf1c | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Anthea Pharma Private Limited | 4e0cff98-ad0e-494d-8316-b7cdfad6a876 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Cardinal Health 107, LLC | 8f8f4ece-de78-4c13-8d9f-c3bb7053019d | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | bb44c7e1-d911-4788-908f-09b7b271969b | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE |
| BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 0e552e3a-cf52-4d74-9381-6cc1b29b4c90 | 2026-04-04 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Hospira, Inc. | 02a845c3-4521-4926-e397-25ab536e7cf6 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Sportpharm LLC | 0e6a55f0-5107-4ea9-9ee1-5c6c09bbe4a6 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Marvona-25 SUIK | BUPIVACAINE HYDROCHLORIDE | Asclemed USA, Inc. | cb71b757-057e-42d4-8a12-8fd8e69a9124 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | Brookfield Pharmaceuticals, LLC. | e8b32972-6984-4f1c-e053-2995a90a3277 | 2026-01-13 | Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | ProPharma Distribution | 42c973e2-307b-924c-e063-6394a90a737a | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | ProPharma Distribution | 3f7ab295-6429-4760-e063-6294a90a781f | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| bupivacaine hydrochloride | BUPIVACAINE HYDROCHLORIDE | Northstar Rx LLC | adadc041-8d5e-4bf8-a89b-e227729a880d | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Sensorcaine | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 2046d833-2974-42fd-a29e-7fc1dc7166cc | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | ONESOURCE SPECIALTY PHARMA LIMITED | 5c10e3a1-7806-40c7-afd2-4c420e141823 | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Bupivacaine Hydrochloride | BUPIVACAINE HYDROCHLORIDE | ONESOURCE SPECIALTY PHARMA LIMITED | 02d0e5f1-5fab-4420-b673-785fd81d7ae2 | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE |
| Sensorcaine MPF | BUPIVACAINE HYDROCHLORIDE | Henry Schein, Inc. | 78c6789d-773e-4b26-90bd-34a6b6d730ce | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | BUPIVACAINE HYDROCHLORIDE |