Application 212719
- Type
- ANDA
- Sponsor
- UNICHEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
| 003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212719-001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | ||
| A212719-002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | ||
| A212719-003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 |
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 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212719-002 | LABETALOL HYDROCHLORIDE | 200MG | TABLET / ORAL | 2022-08-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212719-003 | LABETALOL HYDROCHLORIDE | 300MG | TABLET / ORAL | 2022-08-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212719-001 | LABETALOL HYDROCHLORIDE | 100MG | TABLET / ORAL | 2022-08-08 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212719-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212719-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212719-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A212719-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A212719-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A212719-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A212719-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A212719-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A212719-003 | AB | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Labetalol Hydrochloride | LABETALOL HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | ed0188ba-3fd3-4680-a829-ba242a115fab | 2026-02-25 | Warnings, Adverse reactions | 212719 ANDA212719 29300-253 29300-254 29300-252 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-252 | Labetalol Hydrochloride | Labetalol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-253 | Labetalol Hydrochloride | Labetalol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-254 | Labetalol Hydrochloride | Labetalol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |