Application 206608
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
| 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67457-657 | esmolol hydrochloride in sodium chloride | esmolol hydrochloride in sodium chloride | Mylan Institutional LLC | ANDA | Current |
| 67457-658 | esmolol hydrochloride in sodium chloride | esmolol hydrochloride in sodium chloride | Mylan Institutional LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54893 | ORIG | 2018-07-16 |