Application 077122
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | TABLET;ORAL | 0.1MG | No | No |
| 002 | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | TABLET;ORAL | 0.2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1646 | Desmopressin Acetate | Desmopressin Acetate | Impax Generics | ANDA | Current |
| 0115-1646 | Desmopressin Acetate | Desmopressin Acetate | Impax Generics | ANDA | Current |
| 0115-1647 | Desmopressin Acetate | Desmopressin Acetate | Impax Generics | ANDA | Current |
| 0115-1647 | Desmopressin Acetate | Desmopressin Acetate | Impax Generics | ANDA | Current |
| 0615-7549 | Desmopressin Acetate | Desmopressin Acetate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 68151-1281 | Desmopressin Acetate | Desmopressin Acetate | Carilion Materials Management | ANDA | Current |