Application 203412
- Type
- ANDA
- Sponsor
- HAINAN POLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70436-019 | Azithromycin | Azithromycin Dihydrate | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-019 | Azithromycin | Azithromycin Dihydrate | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-019 | Azithromycin | Azithromycin Dihydrate | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-019 | Azithromycin | Azithromycin Dihydrate | Slate Run Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10209 | ORIG | 2015-10-21 |