Application 090502
- Type
- ANDA
- Sponsor
- FRESENIUS KABI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LACTULOSE | LACTULOSE | SOLUTION;ORAL, RECTAL | 10GM/15ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 18124-002 | Lactulose | Lactulose | Fresenius Kabi Austria GmbH | ANDA | Current |
| 18124-002 | Lactulose | Lactulose | Fresenius Kabi Austria GmbH | ANDA | Current |
| 18124-002 | Lactulose | Lactulose | Fresenius Kabi Austria GmbH | ANDA | Current |
| 45963-438 | Enulose | Lactulose | Actavis Pharma, Inc. | ANDA | Current |
| 45963-438 | Enulose | Lactulose | Actavis Pharma, Inc. | ANDA | Current |
| 63629-8800 | Enulose | Lactulose | Bryant Ranch Prepack | ANDA | Current |
| 63629-8800 | Enulose | Lactulose | Bryant Ranch Prepack | ANDA | Current |