Application 079247
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | TABLET;ORAL | 0.398GM;1.102GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-030 | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | Novel Laboratories, Inc. | ANDA | Current |
| 43386-030 | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate | Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets | Lupin Pharmaceuticals,Inc. | ANDA | Current |