Application 209045
- Type
- ANDA
- Sponsor
- SUNSHINE LAKE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-2370 | azithromycin | AZITHROMYCIN MONOHYDRATE | Lannett Company, Inc. | ANDA | Current |
| 0527-2370 | azithromycin | AZITHROMYCIN MONOHYDRATE | Lannett Company, Inc. | ANDA | Current |
| 0527-2370 | azithromycin | AZITHROMYCIN MONOHYDRATE | Lannett Company, Inc. | ANDA | Current |
| 48792-7869 | azithromycin monohydrate | azithromycin monohydrate | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |