Application 076258
- Type
- ANDA
- Sponsor
- MYLAN TECHNOLOGIES
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 |
| 005 | FENTANYL-12 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 12.5MCG/HR | No | No |
| 006 | FENTANYL-37 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 37.5MCG/HR | No | No |
| 007 | FENTANYL-62 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 62.5MCG/HR | No | No |
| 008 | FENTANYL-87 | FENTANYL | FILM, EXTENDED RELEASE;TRANSDERMAL | 87.5MCG/HR | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0378-9119 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9119 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9119 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9119 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9121 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9121 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9121 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9121 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9122 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9122 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9122 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9122 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9123 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9123 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9123 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9123 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9124 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9124 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9124 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9124 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9125 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9125 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9125 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9125 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9126 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9126 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9126 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9126 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9127 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9127 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9127 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9127 | FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 35356-062 | Fentanyl | fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-062 | Fentanyl | fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-632 | FENTANYL | FENTANYL | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-632 | FENTANYL | FENTANYL | Quality Care Products, LLC | ANDA | Current |
| 35356-632 | FENTANYL | FENTANYL | Quality Care Products, LLC | ANDA | Current |
| 35356-633 | FENTANYL | FENTANYL | Quality Care Products, LLC | ANDA | Current |
| 35356-634 | FENTANYL | FENTANYL | Quality Care Products, LLC | ANDA | Current |
| 35356-634 | FENTANYL | FENTANYL | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-634 | FENTANYL | FENTANYL | Quality Care Products, LLC | ANDA | Current |
| 35356-635 | Fentanyl | fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-635 | Fentanyl | fentanyl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24053 | ORIG | 2015-06-30 |
| 22551 | ORIG | 2005-07-22 |
| 31105 | ORIG | 2005-02-01 |
| 31104 | ORIG | 2004-06-24 |