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Application 212268
- Type
- NDA
- Sponsor
- HISAMITSU
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SECUADO | ASENAPINE | SYSTEM;TRANSDERMAL | 3.8MG/24HR | Yes | No |
| 002 | SECUADO | ASENAPINE | SYSTEM;TRANSDERMAL | 5.7MG/24HR | Yes | No |
| 003 | SECUADO | ASENAPINE | SYSTEM;TRANSDERMAL | 7.6MG/24HR | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68968-0172 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0172 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0172 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0172 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0173 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0173 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0173 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0173 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0174 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0174 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0174 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
| 68968-0174 | SECUADO | ASENAPINE | Noven Therapeutics, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81164 | SUPPL | 2025-02-07 |
| 80934 | SUPPL | 2025-02-05 |
| 61641 | ORIG | 2020-01-24 |
| 60609 | ORIG | 2019-10-21 |
| 60562 | ORIG | 2019-10-15 |