Application 020355
- Type
- NDA
- Sponsor
- FERRING PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | STIMATE | DESMOPRESSIN ACETATE | SPRAY, METERED;NASAL | 0.15MG/SPRAY | No | No |
| 002 | STIMATE (NEEDS NO REFRIGERATION) | DESMOPRESSIN ACETATE | SPRAY, METERED;NASAL | 0.15MG/SPRAY | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0053-6871 | Stimate | DESMOPRESSIN ACETATE | CSL Behring LLC | NDA | Current |
| 0053-6871 | Stimate | DESMOPRESSIN ACETATE | CSL Behring LLC | NDA | Current |
| 0053-6871 | Stimate | DESMOPRESSIN ACETATE | CSL Behring LLC | NDA | Current |
| 0053-6871 | Stimate | DESMOPRESSIN ACETATE | CSL Behring LLC | NDA | Current |
| 0053-6871 | Stimate | DESMOPRESSIN ACETATE | CSL Behring LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24812 | SUPPL | 2013-06-12 |
| 34534 | SUPPL | 2013-06-10 |
| 12467 | SUPPL | 2013-06-04 |
| 2367 | SUPPL | 2013-05-28 |
| 2366 | SUPPL | 2011-09-21 |
| 34533 | SUPPL | 2011-09-20 |
| 23577 | ORIG | 2007-12-04 |
| 24811 | SUPPL | 2007-11-08 |
| 12466 | SUPPL | 2007-11-07 |
| 24810 | SUPPL | 2002-08-21 |