Application 219535
- Type
- ANDA
- Sponsor
- ANTHEA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1% | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219535-001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | |
| A219535-002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219535-001 | AP |
| A219535-002 | 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 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219535-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-001 | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE / INJECTION | AP | 2025-04-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-002 | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE / INJECTION | AP | 2026-02-06 | 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 | A219535-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219535-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219535-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219535-001 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219535-002 | 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 |
|---|---|---|---|---|---|---|
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Anthea Pharma Private Limited | 240c4744-e58c-4c08-93ad-8d6418c4f8a9 | 2026-02-11 | Warnings, Adverse reactions | 219535 ANDA219535 |
| lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Avenacy, LLC | 46480253-29b9-4d7f-98ed-10377929026b | 2026-01-13 | Warnings, Adverse reactions | 219535 ANDA219535 |
| lidocaine hydrochloride | LIDOCAINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 4643042c-ec95-3bad-e063-6294a90a8250 | 2025-12-18 | Warnings, Adverse reactions | 219535 ANDA219535 |