Application 074712
- Type
- ANDA
- Sponsor
- CUMBERLAND PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LACTULOSE | LACTULOSE | FOR SOLUTION;ORAL | 10GM/PACKET | No | Yes |
| 002 | LACTULOSE | LACTULOSE | FOR SOLUTION;ORAL | 20GM/PACKET | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66220-719 | Kristalose | lactulose | Cumberland Pharmaceuticals Inc. | ANDA | Current |
| 66220-719 | KRISTALOSE | lactulose | Cumberland Pharmaceuticals Inc. | ANDA | Current |
| 66220-729 | Kristalose | lactulose | Cumberland Pharmaceuticals Inc. | ANDA | Current |
| 66220-729 | KRISTALOSE | lactulose | Cumberland Pharmaceuticals Inc. | ANDA | Current |
| 69067-010 | Lactulose | Lactulose | Foxland Pharmaceuticals, Inc. | ANDA | Current |
| 69067-010 | Lactulose | Lactulose | Foxland Pharmaceuticals, Inc. | ANDA | Current |
| 69067-010 | Lactulose | Lactulose | Foxland Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42861 | ORIG | 2011-12-14 |