Application 208129
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | No | No |
| 002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | No | No |
| 003 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | No | No |
| 004 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-671 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-671 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-671 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53617 | ORIG | 2018-12-20 |