Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017857
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STADOL BUTORPHANOL TARTRATE 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
STADOL PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
STADOL PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
08/22/1978 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
11/05/2001 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/25/1999 SUPPL-54 Labeling

Label is not available on this site.

03/13/1998 SUPPL-53 Labeling

Label is not available on this site.

03/13/1998 SUPPL-51 Labeling

Label is not available on this site.

04/16/1993 SUPPL-50 Labeling

Label is not available on this site.

04/16/1993 SUPPL-49 Labeling

Label is not available on this site.

05/01/1992 SUPPL-48 Labeling

Label is not available on this site.

09/19/1990 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

12/12/1988 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1987 SUPPL-43 Labeling

Label is not available on this site.

01/14/1987 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1986 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1987 SUPPL-39 Efficacy-New Dosing Regimen

Label is not available on this site.

01/10/1985 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/22/1985 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/19/1984 SUPPL-35 Labeling

Label is not available on this site.

06/07/1984 SUPPL-34 Labeling

Label is not available on this site.

06/07/1984 SUPPL-33 Labeling

Label is not available on this site.

05/09/1984 SUPPL-32 Labeling

Label is not available on this site.

04/16/1984 SUPPL-31 Labeling

Label is not available on this site.

04/04/1984 SUPPL-30 Labeling

Label is not available on this site.

10/24/1984 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1984 SUPPL-26 Labeling

Label is not available on this site.

09/07/1983 SUPPL-25 Labeling

Label is not available on this site.

04/20/1983 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1982 SUPPL-22 Efficacy-New Patient Population

Label is not available on this site.

05/14/1981 SUPPL-20 Labeling

Label is not available on this site.

05/14/1981 SUPPL-19 Labeling

Label is not available on this site.

09/02/1981 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/03/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1987 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1979 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/20/1979 SUPPL-9 Labeling

Label is not available on this site.

11/20/1979 SUPPL-7 Labeling

Label is not available on this site.

11/20/1979 SUPPL-6 Labeling

Label is not available on this site.

11/20/1979 SUPPL-5 Labeling

Label is not available on this site.

09/14/1978 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1978 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/14/1978 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/14/1978 SUPPL-1 Labeling

Label is not available on this site.

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