Application 022517
- Type
- NDA
- Sponsor
- FERRING PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NOCDURNA | DESMOPRESSIN ACETATE | TABLET;SUBLINGUAL | 0.0277MG | Yes | No |
| 002 | NOCDURNA | DESMOPRESSIN ACETATE | TABLET;SUBLINGUAL | 0.0553MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54436-325 | NOCDURNA | DESMOPRESSIN ACETATE | Antares Pharma, Inc. | NDA | Current |
| 54436-325 | NOCDURNA | DESMOPRESSIN ACETATE | Antares Pharma, Inc. | NDA | Current |
| 54436-350 | NOCDURNA | DESMOPRESSIN ACETATE | Antares Pharma, Inc. | NDA | Current |
| 54436-350 | NOCDURNA | DESMOPRESSIN ACETATE | Antares Pharma, Inc. | NDA | Current |
| 55566-5050 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5050 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5050 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5050 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5070 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5070 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5070 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-5070 | NOCDURNA | DESMOPRESSIN ACETATE | Ferring Pharmaceuticals Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 54661 | ORIG | 2019-05-13 |
| 54660 | ORIG | 2018-06-21 |
| 54659 | ORIG | 2018-06-21 |
| 54658 | ORIG | 2018-06-21 |