Application 074076
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LACTULOSE | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50383-779 | Lactulose | Lactulose | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-779 | Lactulose | Lactulose | Akorn | ANDA | Current |
| 50383-779 | Lactulose | Lactulose | Akorn | ANDA | Current |
| 50383-779 | Lactulose | Lactulose | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-779 | Lactulose | Lactulose | Akorn | ANDA | Current |
| 50436-3101 | Lactulose | Lactulose | Unit Dose Services | ANDA | Current |
| 53217-009 | Lactulose | Lactulose | Aidarex Pharmaceuticals LLC | ANDA | Current |