Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETHRANE | ENFLURANE | 99.9% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID;INHALATION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/28/1972 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/2010 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017087s048ltr.pdf | |
| 09/20/2006 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017087s047ltr.pdf | |
| 10/08/2002 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17087slr045ltr.pdf |
| 09/22/2000 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1996 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1995 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 03/21/1990 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1987 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 03/24/1985 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1985 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 06/06/1984 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 04/17/1985 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/24/1981 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1981 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1982 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/24/1980 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/1979 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1980 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 12/04/1979 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/06/1979 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1979 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1977 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/30/1978 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/03/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/04/1976 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1976 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1976 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1975 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/18/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/11/1974 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1974 | SUPPL-4 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/21/2010 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017087s048lbl.pdf | |
| 09/20/2006 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017087s047lbl.pdf |