Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011338
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOTHANE HALOTHANE 99.99% 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
03/12/1958 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
04/29/1996 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/29/1996 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-15 Labeling

Label is not available on this site.

07/30/1987 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/01/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1981 SUPPL-9 Labeling

Label is not available on this site.

12/01/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1979 SUPPL-7 Labeling

Label is not available on this site.

10/23/1978 SUPPL-6 Labeling

Label is not available on this site.

10/28/1975 SUPPL-5 Labeling

Label is not available on this site.

10/28/1975 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

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