Application 213593
- Type
- NDA
- Sponsor
- AZURITY PAHRMACEUTICALS, INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KONVOMEP | OMEPRAZOLE AND SODIUM BICARBONATE | SUSPENSION;ORAL | 2MG; 84MG / ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65628-272 | Konvomep | omeprazole and sodium bicarbonate | Azurity Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75199 | ORIG | 2023-08-22 |
| 71975 | ORIG | 2022-09-01 |
| 71984 | ORIG | 2022-08-31 |
| 71983 | ORIG | 2022-08-31 |