Application 077414
- Type
- ANDA
- Sponsor
- APOTEX 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 |
|---|
| 60505-0257 | Desmopressin Acetate | desmopressin acetate | Apotex Corp. | ANDA | Current |
| 60505-0257 | Desmopressin Acetate | desmopressin acetate | Apotex Corp. | ANDA | Current |
| 60505-0257 | Desmopressin Acetate | desmopressin acetate | Apotex Corp. | ANDA | Current |
| 60505-0258 | Desmopressin Acetate | desmopressin acetate | Apotex Corp. | ANDA | Current |
| 60505-0258 | Desmopressin Acetate | desmopressin acetate | Apotex Corp. | ANDA | Current |
| 60505-0258 | Desmopressin Acetate | desmopressin acetate | Apotex Corp. | ANDA | Current |
| 70518-3148 | Desmopressin Acetate | desmopressin acetate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3149 | Desmopressin Acetate | desmopressin acetate | REMEDYREPACK INC. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 52730 | SUPPL | 2018-02-27 |