Application 022536
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | INDOMETHACIN | INDOMETHACIN | INJECTABLE;INJECTION | EQ 1MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-659 | Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-659 | Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-659 | Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-659 | Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-659 | Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-659 | Indomethacin | INDOMETHACIN | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69741 | SUPPL | 2021-12-22 |
| 69740 | SUPPL | 2021-12-22 |
| 44774 | ORIG | 2010-08-02 |
| 22050 | ORIG | 2010-08-02 |
| 29842 | ORIG | 2010-03-22 |
| 17691 | ORIG | 2010-03-18 |