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Application 209592
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | No | No |
| 002 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67457-562 | Baclofen | Baclofen | Mylan Institutional LLC | ANDA | Current |
| 67457-562 | Baclofen | Baclofen | Mylan Institutional LLC | ANDA | Current |
| 67457-564 | Baclofen | Baclofen | Mylan Institutional LLC | ANDA | Current |
| 67457-564 | Baclofen | Baclofen | Mylan Institutional LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53498 | ORIG | 2018-03-28 |
| 53142 | ORIG | 2018-03-22 |