Application 090503
- Type
- ANDA
- Sponsor
- FRESENIUS KABI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LACTULOSE | LACTULOSE | SOLUTION;ORAL | 10GM/15ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 18124-001 | Lactulose | Lactulose | Fresenius Kabi Austria GmbH | ANDA | Current |
| 45963-439 | Constulose | Lactulose | Actavis Pharma, Inc. | ANDA | Current |
| 45963-439 | Constulose | Lactulose | Actavis Pharma, Inc. | ANDA | Current |
| 50090-3436 | Constulose | Lactulose | A-S Medication Solutions | ANDA | Current |
| 50090-3436 | Constulose | Lactulose | A-S Medication Solutions | ANDA | Current |