Application 211746
- Type
- NDA
- Sponsor
- GLENMARK SPECIALTY SA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RYALTRIS | OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE MONOHYDRATE | SPRAY, METERED;NASAL | 665MCG/25MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59467-700 | Ryaltris | olopatadine hydrochloride and mometasone furoate | HIKMA SPECIALTY USA INC. | NDA | Current |
| 59467-700 | Ryaltris | olopatadine hydrochloride and mometasone furoate | HIKMA SPECIALTY USA INC. | NDA | Current |
| 59467-700 | Ryaltris | olopatadine hydrochloride and mometasone furoate | HIKMA SPECIALTY USA INC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75328 | SUPPL | 2023-08-31 |
| 75319 | SUPPL | 2023-08-30 |
| 74622 | SUPPL | 2023-06-26 |
| 74621 | SUPPL | 2023-06-26 |
| 73138 | ORIG | 2023-01-10 |
| 72253 | SUPPL | 2022-10-05 |
| 72211 | SUPPL | 2022-10-03 |
| 69895 | ORIG | 2022-01-18 |
| 69893 | ORIG | 2022-01-18 |