Application 017624
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FORANE | ISOFLURANE | LIQUID;INHALATION | 99.9% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10019-360 | FORANE | isoflurane | Baxter Healthcare Corporation | NDA | Current |
| 10019-360 | FORANE | isoflurane | Baxter Healthcare Corporation | NDA | Current |
| 10019-360 | FORANE | isoflurane | Baxter Healthcare Corporation | NDA | Current |
| 10019-360 | FORANE | isoflurane | Baxter Healthcare Corporation | NDA | Current |
| 10019-360 | FORANE | isoflurane | Baxter Healthcare Corporation | NDA | Current |
| 10019-360 | FORANE | isoflurane | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80549 | SUPPL | 2024-12-10 |
| 80544 | SUPPL | 2024-12-10 |
| 72545 | SUPPL | 2022-11-02 |
| 72530 | SUPPL | 2022-11-02 |
| 69124 | SUPPL | 2021-10-26 |
| 69115 | SUPPL | 2021-10-26 |
| 48218 | SUPPL | 2017-05-02 |
| 48190 | SUPPL | 2017-05-02 |
| 11049 | SUPPL | 2010-03-03 |
| 666 | SUPPL | 2010-02-26 |
| 13869 | SUPPL | 2006-09-18 |
| 33319 | SUPPL | 2006-09-01 |