Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FORANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | AN | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/1979 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017624s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017624Orig1s042ltr.pdf | |
| 04/27/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017624s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017624Orig1s041ltr.pdf | |
| 10/25/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017624s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017624Orig1s040ltr.pdf | |
| 02/21/2013 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2010 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017624s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017624s036ltr.pdf | |
| 08/31/2006 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017624s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017624s034ltr.pdf | |
| 09/27/2002 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/01/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1999 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1996 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1996 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/05/1995 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/16/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/25/1987 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/17/1985 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/15/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/02/1985 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1984 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1983 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/09/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/22/1982 | SUPPL-7 | Efficacy |
Label is not available on this site. |
||
| 09/29/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/1981 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/26/1981 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/26/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/26/1981 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017624s042lbl.pdf | |
| 10/25/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017624s040lbl.pdf | |
| 04/27/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017624s041lbl.pdf | |
| 02/22/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017624s036lbl.pdf | |
| 08/31/2006 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017624s034lbl.pdf |
FORANE
LIQUID;INHALATION; 99.9%
TE Code = AN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FORANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | Yes | AN | 017624 | BAXTER HLTHCARE |
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | No | AN | 075225 | HALOCARBON PRODS |
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | No | AN | 074416 | PIRAMAL CRITICAL |
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | Prescription | No | AN | 074502 | PIRAMAL PHARMA |