Application 078401
- Type
- ANDA
- Sponsor
- NORTHSTAR HLTHCARE
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BACLOFEN | BACLOFEN | TABLET;ORAL | 20MG | No | No |
| 002 | BACLOFEN | BACLOFEN | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-072 | Baclofen | Baclofen | Northstar RxLLC | ANDA | Current |
| 16714-072 | Baclofen | Baclofen | Northstar RxLLC | ANDA | Current |
| 16714-072 | Baclofen | Baclofen | Northstar RxLLC | ANDA | Current |
| 63739-480 | Baclofen | Baclofen | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-480 | Baclofen | Baclofen | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-480 | Baclofen | Baclofen | McKesson Corporation | ANDA | Current |
| 63739-480 | Baclofen | Baclofen | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 71610-446 | Baclofen | Baclofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-446 | Baclofen | Baclofen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 80425-0081 | Baclofen | Baclofen 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0081 | Baclofen | Baclofen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0081 | Baclofen | Baclofen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0081 | Baclofen | Baclofen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |