Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017892
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALCION TRIAZOLAM 0.25MG TABLET;ORAL Prescription AB Yes Yes
HALCION TRIAZOLAM 0.5MG TABLET;ORAL Discontinued None No No
HALCION TRIAZOLAM 0.125MG TABLET;ORAL Prescription AB 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
11/15/1982 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
02/06/2019 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017892Orig1s054ltr.pdf
12/16/2016 SUPPL-49 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017892Orig1s049ltr.pdf
12/15/2015 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/18/2014 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017892s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017892Orig1s047ltr.pdf
01/21/2014 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/25/2013 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/12/2008 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017892s038ltr.pdf
11/04/1999 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/25/2003 SUPPL-34 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17892slr034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017892_s034_HalcionTOC.cfm
04/04/1996 SUPPL-33 Labeling

Label is not available on this site.

11/04/1994 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/14/1993 SUPPL-30 Labeling

Label is not available on this site.

05/25/1993 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1992 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/13/1991 SUPPL-23 Labeling

Label is not available on this site.

01/17/1991 SUPPL-22 Labeling

Label is not available on this site.

05/21/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1990 SUPPL-19 Labeling

Label is not available on this site.

08/16/1990 SUPPL-18 Labeling

Label is not available on this site.

08/16/1990 SUPPL-17 Labeling

Label is not available on this site.

03/20/1989 SUPPL-16 Labeling

Label is not available on this site.

05/06/1988 SUPPL-15 Labeling

Label is not available on this site.

05/05/1988 SUPPL-14 Labeling

Label is not available on this site.

07/26/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/25/1988 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1987 SUPPL-11 Labeling

Label is not available on this site.

10/23/1987 SUPPL-10 Labeling

Label is not available on this site.

08/24/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1987 SUPPL-8 Labeling

Label is not available on this site.

10/23/1987 SUPPL-7 Labeling

Label is not available on this site.

12/06/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/26/1985 SUPPL-4 Labeling

Label is not available on this site.

10/23/1987 SUPPL-2 Labeling

Label is not available on this site.

04/26/1985 SUPPL-1 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-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s054lbl.pdf
12/16/2016 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf
12/16/2016 SUPPL-49 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf
09/18/2014 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017892s047lbl.pdf
02/12/2008 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf

HALCION

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCION TRIAZOLAM 0.25MG TABLET;ORAL Prescription Yes AB 017892 PHARMACIA AND UPJOHN
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074031 MYLAN PHARMS INC
TRIAZOLAM TRIAZOLAM 0.25MG TABLET;ORAL Prescription No AB 074224 WEST-WARD PHARMS INT

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALCION TRIAZOLAM 0.125MG TABLET;ORAL Prescription Yes AB 017892 PHARMACIA AND UPJOHN
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 074031 MYLAN PHARMS INC
TRIAZOLAM TRIAZOLAM 0.125MG TABLET;ORAL Prescription No AB 074224 WEST-WARD PHARMS INT

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