Application 204633
- Type
- ANDA
- Sponsor
- SIGMAPHARM LABS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ACITRETIN | ACITRETIN | CAPSULE;ORAL | 10MG | No | No |
| 002 | ACITRETIN | ACITRETIN | CAPSULE;ORAL | 17.5MG | No | No |
| 003 | ACITRETIN | ACITRETIN | CAPSULE;ORAL | 22.5MG | No | No |
| 004 | ACITRETIN | ACITRETIN | CAPSULE;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42291-086 | ACITRETIN | ACITRETIN | AvKARE | ANDA | Current |
| 42291-086 | ACITRETIN | ACITRETIN | AvKARE, Inc. | ANDA | Current |
| 42291-087 | ACITRETIN | ACITRETIN | AvKARE, Inc. | ANDA | Current |
| 42291-087 | ACITRETIN | ACITRETIN | AvKARE | ANDA | Current |
| 42291-088 | ACITRETIN | ACITRETIN | AvKARE, Inc. | ANDA | Current |
| 42291-088 | ACITRETIN | ACITRETIN | AvKARE | ANDA | Current |
| 42794-080 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-080 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-080 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-080 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-081 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-081 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-081 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-081 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-083 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-083 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-083 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-083 | ACITRETIN | ACITRETIN | Sigmapharm Laboratories, LLC | ANDA | Current |