FDA.reportPublic FDA data

Application 017892

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALCIONTRIAZOLAMTABLET;ORAL0.25MGYesYes
002HALCIONTRIAZOLAMTABLET;ORAL0.5MGNoNo
003HALCIONTRIAZOLAMTABLET;ORAL0.125MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0017HalciontriazolamPharmacia and Upjohn CompNDACurrent
0009-0017HalciontriazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0017HalciontriazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0017HalciontriazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0017HalciontriazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0017HalciontriazolamPharmacia and Upjohn Company LLCNDACurrent
43353-451TriazolamtriazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
50090-0522TriazolamtriazolamA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0522TriazolamtriazolamA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50436-3718TriazolamtriazolamUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
55289-787TriazolamtriazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-787TriazolamtriazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-787TriazolamtriazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-787TriazolamtriazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-787TriazolamtriazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
59762-3717TriazolamtriazolamGreenstone LLCNDA AUTHORIZED Current
59762-3717TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3717TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3717TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3717TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3717TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3718TriazolamtriazolamGreenstone LLCNDA AUTHORIZED Current
59762-3718TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3718TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3718TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3718TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3718TriazolamtriazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73197SUPPL2023-01-17
73196SUPPL2023-01-17
73169SUPPL2023-01-17
69170SUPPL2021-10-29
69146SUPPL2021-10-29
69148SUPPL2021-10-28
66186SUPPL2021-02-11
66185SUPPL2021-02-11
66128SUPPL2021-02-09
60532SUPPL2019-10-10
60531SUPPL2019-10-10
60511SUPPL2019-10-10
57595SUPPL2019-02-14
57474SUPPL2019-02-07
46463SUPPL2016-12-22
46315SUPPL2016-12-20
13946SUPPL2014-09-23
33365SUPPL2014-09-22
11088SUPPL2008-02-14
740SUPPL2008-02-14
23538ORIG2007-03-16
20096SUPPL2006-05-08
13945SUPPL2003-07-06