Application 076709
- Type
- ANDA
- Sponsor
- ACTAVIS LABS UT INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENTANYL-25 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 25MCG/HR | No | No |
| 002 | FENTANYL-50 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 50MCG/HR | No | No |
| 003 | FENTANYL-75 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 75MCG/HR | No | No |
| 004 | FENTANYL-100 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 100MCG/HR | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3198 | Fentanyl | Fentanyl | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3212 | Fentanyl | Fentanyl | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3213 | Fentanyl | Fentanyl | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3214 | Fentanyl | Fentanyl | Actavis Pharma, Inc. | ANDA | Current |
| 49999-831 | Fentanyl | Fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-832 | Fentanyl | Fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-833 | Fentanyl | Fentanyl | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 49999-834 | Fentanyl | Fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24057 | ORIG | 2015-06-30 |
| 44317 | ORIG | 2012-07-27 |