Application 202148
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACITRETIN | ACITRETIN | CAPSULE;ORAL | 10MG | No | No |
| 002 | ACITRETIN | ACITRETIN | CAPSULE;ORAL | 25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7020 | Acitretin | acitretin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7020 | Acitretin | acitretin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7023 | Acitretin | acitretin | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-7023 | Acitretin | acitretin | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32193 | ORIG | 2015-09-15 |