Application 017922
- Type
- NDA
- Sponsor
- FERRING PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DDAVP | DESMOPRESSIN ACETATE | SOLUTION;NASAL | 0.01% | Yes | Yes |
| 002 | DDAVP | DESMOPRESSIN ACETATE | SPRAY, METERED;NASAL | 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | DDAVP (NEEDS NO REFRIGERATION) | DESMOPRESSIN ACETATE | SPRAY, METERED;NASAL | 0.01MG/SPRAY | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2400 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2500 | DDAVP | Desmopressin Acetate | Ferring Pharmaceuticals Inc. | NDA | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-501 | Desmopressin Acetate | Desmopressin Acetate | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56090 | SUPPL | 2018-10-24 |
| 56085 | SUPPL | 2018-10-23 |
| 33371 | SUPPL | 2015-11-19 |
| 749 | SUPPL | 2015-11-09 |
| 44015 | ORIG | 2007-12-04 |
| 13955 | SUPPL | 2007-11-08 |
| 11094 | SUPPL | 2007-11-07 |
| 13954 | SUPPL | 2005-11-17 |
| 33370 | SUPPL | 2005-11-16 |
| 748 | SUPPL | 2003-11-25 |