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Application 203922
- Type
- NDA
- Sponsor
- HOPE PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM NITRITE | SODIUM NITRITE | SOLUTION;INTRAVENOUS | 300MG/10ML (30MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60267-311 | Sodium Nitrite | Sodium Nitrite | Hope Pharmaceuticals | NDA | Current |
| 60267-311 | Sodium Nitrite | Sodium Nitrite | Hope Pharmaceuticals | NDA | Current |
| 60267-311 | Sodium Nitrite | Sodium Nitrite | Hope Pharmaceuticals | NDA | Current |
| 60267-311 | Sodium Nitrite | Sodium Nitrite | Hope Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65907 | SUPPL | 2021-01-14 |
| 65905 | SUPPL | 2021-01-14 |
| 50160 | SUPPL | 2017-10-24 |
| 50133 | SUPPL | 2017-10-23 |
| 44890 | ORIG | 2012-03-15 |
| 43447 | ORIG | 2012-03-15 |
| 32478 | ORIG | 2012-02-21 |
| 19502 | ORIG | 2012-02-17 |