Application 219883
- Type
- ANDA
- Sponsor
- ANTHEA PHARMA
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 | 200MG/20ML (10MG/ML) | No | No |
| 004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 20MG/10ML (2MG/ML) | No | No |
| 005 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 100MG/20ML (5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219883-001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | |
| A219883-002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | |
| A219883-003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | |
| A219883-004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | |
| A219883-005 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219883-001 | AP |
| A219883-002 | AP |
| A219883-003 | AP |
| A219883-004 | AP |
| A219883-005 | AP |
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 | A219883-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-003 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-004 | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-005 | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-003 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-004 | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-005 | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219883-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219883-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219883-003 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-001 | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-002 | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-003 | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | AP | 2025-03-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-004 | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-005 | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION / INJECTION | AP | 2025-10-08 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219883-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219883-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219883-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219883-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A219883-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A219883-003 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-003 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-004 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219883-005 | AP | 1 | a50c72e98297… |
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 | Glenmark Pharmaceuticals Inc., USA | 043b28cc-ce5c-4351-a646-704c381decb9 | 2026-03-09 | Warnings, Adverse reactions | 219883 ANDA219883 |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | Anthea Pharma Private Limited | f2b54355-a596-4f97-aeaa-d93e3984c42d | 2025-11-01 | Warnings, Adverse reactions | 219883 ANDA219883 |