Application 203479
- Type
- NDA
- Sponsor
- TASMAN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERSACLOZ | CLOZAPINE | SUSPENSION;ORAL | 50MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 18860-121 | VERSACLOZ | Clozapine | Jazz Pharmaceuticals, Inc. | NDA | Current |
| 52817-601 | VERSACLOZ | Clozapine | TruPharma, LLC | NDA | Current |
| 52817-601 | VERSACLOZ | Clozapine | TruPharma LLC | NDA | Current |
| 52817-601 | VERSACLOZ | Clozapine | TruPharma LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82584 | SUPPL | 2025-06-16 |
| 82583 | SUPPL | 2025-06-16 |
| 82581 | SUPPL | 2025-06-16 |
| 81084 | SUPPL | 2025-02-06 |
| 80937 | SUPPL | 2025-02-05 |
| 74103 | SUPPL | 2023-04-27 |
| 74094 | SUPPL | 2023-04-27 |
| 69294 | SUPPL | 2021-11-12 |
| 68256 | SUPPL | 2021-08-02 |
| 66306 | SUPPL | 2021-02-22 |
| 64149 | SUPPL | 2020-07-30 |
| 64138 | SUPPL | 2020-07-30 |
| 62572 | SUPPL | 2020-04-15 |
| 62570 | SUPPL | 2020-04-15 |
| 57302 | SUPPL | 2019-01-22 |
| 47394 | SUPPL | 2017-03-02 |
| 47352 | SUPPL | 2017-02-27 |
| 40303 | SUPPL | 2015-12-10 |
| 10222 | SUPPL | 2015-10-02 |
| 32432 | SUPPL | 2015-09-17 |
| 10221 | SUPPL | 2015-09-17 |
| 40302 | SUPPL | 2015-09-16 |
| 19476 | SUPPL | 2015-09-16 |
| 19474 | SUPPL | 2014-01-13 |
| 10219 | SUPPL | 2013-12-09 |
| 44885 | ORIG | 2013-09-20 |
| 43436 | ORIG | 2013-09-20 |
| 19475 | SUPPL | 2013-08-27 |
| 10220 | SUPPL | 2013-08-23 |
| 40301 | ORIG | 2013-02-08 |
| 32431 | ORIG | 2013-02-08 |
| 24115 | ORIG | 2013-02-08 |