Application 022306
- Type
- NDA
- Sponsor
- ALTATHERA PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 150MG/10ML (15MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69724-112 | Sotalol hydrochloride | Sotalol hydrochloride | ALTATHERA Pharmaceuticals, LLC | NDA | Current |
| 69724-112 | Sotalol hydrochloride | Sotalol hydrochloride | ALTATHERA Pharmaceuticals, LLC | NDA | Current |
| 69724-112 | Sotalol hydrochloride | Sotalol hydrochloride | ALTATHERA Pharmaceuticals, LLC | NDA | Current |
| 69724-112 | Sotalol hydrochloride | Sotalol hydrochloride | ALTATHERA Pharmaceuticals, LLC | NDA | Current |
| 69724-112 | Sotalol hydrochloride | Sotalol hydrochloride | ALTATHERA Pharmaceuticals, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82936 | SUPPL | 2025-07-25 |
| 82919 | SUPPL | 2025-07-25 |
| 75545 | SUPPL | 2023-09-22 |
| 75536 | SUPPL | 2023-09-22 |
| 62099 | SUPPL | 2020-03-13 |
| 62086 | SUPPL | 2020-03-09 |
| 44732 | ORIG | 2010-03-30 |
| 42483 | ORIG | 2010-03-30 |
| 38538 | ORIG | 2009-07-09 |
| 7207 | ORIG | 2009-07-09 |