Application 215732
- Type
- ANDA
- Sponsor
- HAINAN POLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | INJECTABLE;INTRAVENOUS | EQ 40MG BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 14335-060 | Esomeprazole sodium | Esomeprazole sodium | Hainan Poly Pharm. Co., Ltd. | ANDA | Current |
| 70436-190 | Esomeprazole sodium | Esomeprazole sodium | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-190 | Esomeprazole sodium | Esomeprazole sodium | Slate Run Pharmaceuticals, LLC | ANDA | Current |