Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017892
Company: PFIZER
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017892s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017892Orig1s057ltr.pdf | |
| 10/27/2021 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017892Orig1s056ltr.pdf | |
| 02/05/2021 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017892Orig1s055ltr.pdf | |
| 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 | |
| 10/09/2019 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017892Orig1s050ltr.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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017892s057lbl.pdf | |
| 10/27/2021 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s056lbl.pdf | |
| 02/05/2021 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s055lbl.pdf | |
| 10/09/2019 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s050lbl.pdf | |
| 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 | PFIZER |
| TRIAZOLAM | TRIAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 214219 | NOVAST LABS |
| TRIAZOLAM | TRIAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 216890 | SANDOZ |
| TRIAZOLAM | TRIAZOLAM | 0.25MG | TABLET;ORAL | Prescription | No | AB | 213003 | ZYDUS PHARMS |
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 | PFIZER |
| TRIAZOLAM | TRIAZOLAM | 0.125MG | TABLET;ORAL | Prescription | No | AB | 214219 | NOVAST LABS |
| TRIAZOLAM | TRIAZOLAM | 0.125MG | TABLET;ORAL | Prescription | No | AB | 216890 | SANDOZ |
| TRIAZOLAM | TRIAZOLAM | 0.125MG | TABLET;ORAL | Prescription | No | AB | 213003 | ZYDUS PHARMS |