Application 091019
- Type
- ANDA
- Sponsor
- NEXGEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHENODIOL | CHENODIOL | TABLET;ORAL | 250MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0722-7121 | Chenodiol | Chenodiol | Nexgen Pharma, Inc. | ANDA | Current |
| 0722-7121 | Chenodiol | Chenodiol | Nexgen Pharma, Inc. | ANDA | Current |
| 45043-876 | Chenodal | Chenodiol | Manchester Pharmaceuticals Inc. | ANDA | Current |
| 68974-876 | Chenodal | Chenodiol | Retrophin, Inc. | ANDA | Current |
| 68974-876 | Chenodal | Chenodiol | Retrophin, Inc. | ANDA | Current |
| 68974-876 | Chenodal | Chenodiol | Retrophin, Inc. | ANDA | Current |
| 68974-876 | Chenodal | Chenodiol | Retrophin, Inc. | ANDA | Current |
| 68974-876 | Chenodal | Chenodiol | Retrophin, Inc. | ANDA | Current |
| 68974-876 | Chenodal | Chenodiol | Travere Therapeutics | ANDA | Current |
| 79739-7121 | Chenodiol | Chenodiol | LGM Pharma Solutions, LLC | ANDA | Current |