Application 206223
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/VIAL | No | No |
| 002 | REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2MG BASE/VIAL | No | No |
| 003 | REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 5MG BASE/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-723 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-723 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-723 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-723 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-723 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-724 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-724 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-724 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-725 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-725 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-725 | Remifentanil Hydrochloride | Remifentanil Hydrochloride | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 51074 | ORIG | 2018-01-17 |