Skip to contentApplication 215133
- Type
- NDA
- Sponsor
- ALMATICA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZERCAPLI | SERTRALINE HYDROCHORIDE | CAPSULE; ORAL | 150MG | No | No |
| 002 | ZERCAPLI | SERTRALINE HYDROCHORIDE | CAPSULE; ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52427-664 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
| 52427-664 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
| 52427-672 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
| 52427-672 | sertraline HCl | sertraline hydrochloride | Almatica Pharma LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75249 | SUPPL | 2023-08-22 |
| 75187 | SUPPL | 2023-08-21 |
| 75186 | SUPPL | 2023-08-21 |
| 71421 | ORIG | 2022-06-22 |
| 71420 | ORIG | 2022-06-22 |
| 68888 | ORIG | 2021-10-05 |
| 68887 | ORIG | 2021-10-05 |
| 68884 | ORIG | 2021-10-05 |