Application 091193
- Type
- ANDA
- Sponsor
- EMERALD INTL LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 0.05MG/ML | No | No |
| 002 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | No | No |
| 003 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71525-005 | Baclofen (intrathecal) | baclofen | Emerald International Limited | ANDA | Current |
| 71525-010 | Baclofen (intrathecal) | baclofen | Emerald International Limited | ANDA | Current |
| 71525-040 | Baclofen (intrathecal) | baclofen | Emerald International Limited | ANDA | Current |