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Application 207107
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25021-308 | esmolol hydrochloride | esmolol hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-308 | esmolol hydrochloride | esmolol hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-309 | esmolol hydrochloride | esmolol hydrochloride | Sagent Pharmaceuticals | ANDA | Current |
| 25021-309 | esmolol hydrochloride | esmolol hydrochloride | Sagent Pharmaceuticals | ANDA | Current |