Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017087
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHRANE ENFLURANE 99.9% 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

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