Application 090318
- Type
- ANDA
- Sponsor
- MYLAN ASI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 40MG/20ML (2MG/ML) | No | No |
| 002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 150MG/30ML (5MG/ML) | No | No |
| 003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 150MG/20ML (7.5MG/ML) | No | No |
| 004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 200MG/20ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090318-001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ||
| A090318-002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ||
| A090318-003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ||
| A090318-004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090318-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090318-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090318-003 | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090318-004 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | 2014-09-23 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A090318-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090318-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090318-003 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090318-004 | AP | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | A090318-002 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090318-004 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090318-002 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090318-004 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090318-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090318-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090318-003 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090318-004 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090318-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090318-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090318-003 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090318-004 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090318-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090318-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090318-003 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090318-004 | AP | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| ropivacaine hydrochloride | ROPIVACAINE HYDROCHLORIDE | Sagent Pharmaceuticals | 9572b3de-684c-4028-a577-5aa69ba6b02d | 2025-08-06 | Warnings, Adverse reactions | 25021-671 |
| ropivacaine hydrochloride | ROPIVACAINE HYDROCHLORIDE | Sagent Pharmaceuticals | 8c5c762f-d266-4b1a-809e-f11bfc89bc2d | 2025-08-06 | Warnings, Adverse reactions | 25021-671 25021-652 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-652 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-653 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-671 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 67457-875 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-875 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-875 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-876 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-876 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-876 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-877 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-877 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-877 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-878 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-878 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-878 | Ropivacaine Hydrochloride | ropivacaine hydrochloride | Mylan Institutional LLC | ANDA | Current |