Application 214799
- Type
- ANDA
- Sponsor
- BAYSHORE PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METOLAZONE | METOLAZONE | TABLET;ORAL | 2.5MG | No | No |
| 002 | METOLAZONE | METOLAZONE | TABLET;ORAL | 5MG | No | No |
| 003 | METOLAZONE | METOLAZONE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76385-136 | Metolazone | Metolazone | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-136 | Metolazone | Metolazone | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-137 | Metolazone | Metolazone | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-137 | Metolazone | Metolazone | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-138 | Metolazone | Metolazone | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-138 | Metolazone | Metolazone | Bayshore Pharmaceuticals LLC | ANDA | Current |