Application 213330
- Type
- NDA
- Sponsor
- Hikma Pharmaceuticals International Limited
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79456 | SUPPL | 2024-08-21 |
| 79449 | SUPPL | 2024-08-20 |
| 74529 | SUPPL | 2023-06-16 |
| 74515 | SUPPL | 2023-06-16 |
| 73886 | SUPPL | 2023-03-28 |
| 73885 | SUPPL | 2023-03-28 |
| 67918 | ORIG | 2021-06-28 |
| 65197 | ORIG | 2020-11-12 |
| 65179 | ORIG | 2020-11-10 |