Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017624
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
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
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
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 074097 HOSPIRA
ISOFLURANE ISOFLURANE 99.9% LIQUID;INHALATION Prescription No AN 074416 PIRAMAL CRITICAL
ISOFLURANE ISOFLURANE 99.9% LIQUID;INHALATION Prescription No AN 074502 PIRAMAL ENT

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