Application 214267
- Type
- ANDA
- Sponsor
- SINTETICA SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1% | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68055-641 | NA | LIDOCAINE HYDROCHLORIDE | SINTETICA SA | ANDA | Current |
| 68055-642 | NA | LIDOCAINE HYDROCHLORIDE | SINTETICA SA | ANDA | Current |
| 68055-643 | NA | LIDOCAINE HYDROCHLORIDE | SINTETICA SA | ANDA | Current |
| 68055-645 | NA | LIDOCAINE HYDROCHLORIDE | SINTETICA SA | ANDA | Current |
| 68055-646 | NA | LIDOCAINE HYDROCHLORIDE | SINTETICA SA | ANDA | Current |
| 68055-647 | NA | LIDOCAINE HYDROCHLORIDE | SINTETICA SA | ANDA | Current |
| 83090-001 | NA | LIDOCAINE HYDROCHLORIDE | Sintetica US LLC | ANDA | Current |
| 83090-002 | NA | LIDOCAINE HYDROCHLORIDE | Sintetica US LLC | ANDA | Current |
| 83090-003 | NA | LIDOCAINE HYDROCHLORIDE | Sintetica US LLC | ANDA | Current |
| 83090-004 | NA | LIDOCAINE HYDROCHLORIDE | Sintetica US LLC | ANDA | Current |
| 83090-005 | NA | LIDOCAINE HYDROCHLORIDE | Sintetica US LLC | ANDA | Current |
| 83090-006 | NA | LIDOCAINE HYDROCHLORIDE | Sintetica US LLC | ANDA | Current |