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Application 215401
- Type
- NDA
- Sponsor
- NOVEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XELSTRYM | DEXTROAMPHETAMINE | SYSTEM; TRANSDERMAL | 4.5MG/9HR | No | No |
| 002 | XELSTRYM | DEXTROAMPHETAMINE | SYSTEM; TRANSDERMAL | 9MG/9HR | No | No |
| 003 | XELSTRYM | DEXTROAMPHETAMINE | SYSTEM;TRANSDERMAL | 13.5MG/9HR | No | No |
| 004 | XELSTRYM | DEXTROAMPHETAMINE | SYSTEM;TRANSDERMAL | 18.5MG/9HR | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68968-0205 | XELSTRYM | DEXTROAMPHETAMINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0210 | XELSTRYM | DEXTROAMPHETAMINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0215 | XELSTRYM | DEXTROAMPHETAMINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0220 | XELSTRYM | DEXTROAMPHETAMINE | Noven Therapeutics, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83513 | SUPPL | 2025-09-25 |
| 83512 | SUPPL | 2025-09-25 |
| 83465 | SUPPL | 2025-09-25 |
| 80467 | SUPPL | 2024-12-02 |
| 80465 | SUPPL | 2024-12-02 |
| 75807 | SUPPL | 2023-10-17 |
| 71833 | SUPPL | 2022-08-17 |
| 71817 | SUPPL | 2022-08-17 |
| 70994 | ORIG | 2022-05-04 |
| 70602 | ORIG | 2022-03-25 |
| 70589 | ORIG | 2022-03-23 |