Application 202097
- Type
- ANDA
- Sponsor
- 3M DRUG DELIVERY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL-12 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 12.5MCG/HR | No | No |
| 002 | FENTANYL-25 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 25MCG/HR | No | No |
| 003 | FENTANYL-50 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 50MCG/HR | No | No |
| 004 | FENTANYL-75 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 75MCG/HR | No | No |
| 005 | FENTANYL-100 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 100MCG/HR | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-423 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-424 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-426 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-427 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 47781-428 | Fentanyl System | Fentanyl | Alvogen | ANDA | Current |
| 55700-597 | Fentanyl System | Fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-597 | Fentanyl System | Fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-597 | Fentanyl System | Fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-972 | Fentanyl System | Fentanyl | Quality Care Products, LLC | ANDA | Current |
| 55700-973 | Fentanyl System | Fentanyl | Quality Care Products, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76221 | ORIG | 2023-11-03 |