Application 017584
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 2% | No | No |
| 002 | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 4% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1364 | LIDOCAINE HCI | LIDOCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1364 | LIDOCAINE HCI | LIDOCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1364 | LIDOCAINE HCI | LIDOCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1364 | LIDOCAINE HCI | LIDOCAINE HCI | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 63323-208 | Lidocaine | LIDOCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-208 | Lidocaine | LIDOCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-208 | Lidocaine | LIDOCAINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | NDA | Current |