Application 205520
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9858 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc. | ANDA | Current |
| 0404-9858 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc. | ANDA | Current |
| 50090-4512 | Esmolol Hydrochloride | Esmolol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51662-1444 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1444 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1444 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-194 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-194 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-194 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 55150-194 | Esmolol Hydrochloride | Esmolol Hydrochloride | AuroMedics Pharma LLC | ANDA | Current |
| 55150-194 | Esmolol Hydrochloride | Esmolol Hydrochloride | AuroMedics Pharma LLC | ANDA | Current |
| 71872-7049 | Esmolol Hydrochloride | Esmolol Hydrochloride | Medical Purchasing Solutions, LLC | ANDA | Current |
| 71872-7049 | Esmolol Hydrochloride | Esmolol Hydrochloride | Medical Purchasing Solutions, LLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 10458 | ORIG | 2015-07-28 |