Application 213330
- Type
- NDA
- Sponsor
- Hikma Pharmaceuticals International Limited
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 100mg/100mL | No | No |
| 002 | LABETALOL HYDROCHLORIDE IN DEXTROSE | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 200mg/200mL | No | No |
| 003 | LABETALOL HYDROCHLORIDE IN DEXTROSE | LABETALOL HYDROCHLORIDE | INJECTABLE;INJECTION | 300mg/300mL | No | No |
| 004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 300MG/300ML (1MG/ML) | Yes | No |
| 005 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/2ML (5MG/ML) | Yes | No |
| 006 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 20MG/4ML (5MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | LABETALOL HYDROCHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | LABETALOL HYDROCHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | |
| N213330-005 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | |
| N213330-006 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-03-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213330-003 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213330-004 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 300MG/300ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213330-005 | LABETALOL HYDROCHLORIDE | 10MG/2ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-03-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213330-006 | LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-08-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213330-001 | LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N213330-002 | LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-11-09 | 79d66fd596c7… |
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 | Hikma Pharmaceuticals USA Inc. | 99a715a0-4579-410c-b102-7ef6fab8db55 | 2025-12-19 | Warnings, Adverse reactions | 213330 NDA213330 0143-9365 0143-9363 0143-9364 0143-9366 |
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 |
|---|---|---|---|---|---|
| 0143-9363 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9363 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9364 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9364 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9365 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9365 | Labetalol HCl in Sodium Chloride | LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9366 | Labetalol HCl in Dextrose | Labetalol Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-9366 | Labetalol HCl in Dextrose | Labetalol Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6252 | Labetalol Hydrochloride | Labetalol Hydrochloride | Hikma Pharmaceuticals USA Inc. | NDA | Current |