Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 000793
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTISOL SODIUM BUTABARBITAL SODIUM 15MG TABLET;ORAL Discontinued None No No
BUTISOL SODIUM BUTABARBITAL SODIUM 50MG TABLET;ORAL Discontinued None No No
BUTISOL SODIUM BUTABARBITAL SODIUM 30MG TABLET;ORAL Prescription None Yes Yes
BUTISOL SODIUM BUTABARBITAL SODIUM 100MG TABLET;ORAL 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
06/05/1939 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2019 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/000793s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/000793Orig1s026ltr.pdf
09/28/2007 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/000793s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/000793s025ltr.pdf
10/23/2002 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/10/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/21/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/13/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/02/2000 SUPPL-20 Labeling

Label is not available on this site.

11/02/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/14/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/15/1987 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1998 SUPPL-15 Labeling

Label is not available on this site.

02/29/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/15/1984 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1983 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1983 SUPPL-11 Labeling

Label is not available on this site.

11/22/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/22/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/08/1982 SUPPL-8 Labeling

Label is not available on this site.

02/26/1982 SUPPL-7 Labeling

Label is not available on this site.

02/16/1979 SUPPL-6 Labeling

Label is not available on this site.

02/16/1979 SUPPL-5 Labeling

Label is not available on this site.

06/02/1978 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/30/1976 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/000793s026lbl.pdf
09/28/2007 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/000793s025lbl.pdf

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