Application 215846
- Type
- ANDA
- Sponsor
- HAINAN POLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 10MG/50ML (0.2MG/ML) | No | No |
| 002 | SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | No | No |
| 003 | SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | SOLUTION;INTRAVENOUS | 50MG/100ML (0.5MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 14335-132 | Sodium Nitroprusside | Sodium Nitroprusside | Hainan Poly Pharm. Co., Ltd. | ANDA | Current |
| 14335-133 | Sodium Nitroprusside | Sodium Nitroprusside | Hainan Poly Pharm. Co., Ltd. | ANDA | Current |
| 14335-134 | Sodium Nitroprusside | Sodium Nitroprusside | Hainan Poly Pharm. Co., Ltd. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72024 | ORIG | 2022-09-07 |