FDA.reportPublic FDA data

Application 018276

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XANAXALPRAZOLAMTABLET;ORAL0.25MGYesNo
002XANAXALPRAZOLAMTABLET;ORAL0.5MGYesNo
003XANAXALPRAZOLAMTABLET;ORAL1MGYesYes
004XANAXALPRAZOLAMTABLET;ORAL2MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0029XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0029XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0055XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0090XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0094XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
49999-252AlprazolamAlprazolamQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
49999-252AlprazolamAlprazolamQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
49999-252AlprazolamAlprazolamQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
50090-4950AlprazolamalprazolamA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4950AlprazolamalprazolamA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
53002-0340AlprazolamalprazolamRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
53002-0340AlprazolamalprazolamRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3719AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3720AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3721AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3722AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
63187-971AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-971AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
63629-3308AlprazolamalprazolamBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
67046-963AlprazolamalprazolamContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67046-964AlprazolamalprazolamContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67046-965AlprazolamalprazolamContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67544-347AlprazolamalprazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
67544-414AlprazolamalprazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
67544-415AlprazolamalprazolamAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
70518-2785AlprazolamalprazolamREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2785AlprazolamalprazolamREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71205-614AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-652AlprazolamalprazolamProficient Rx LPNDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
72789-087AlprazolamalprazolamPD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73417SUPPL 2023-02-08
73234SUPPL2023-01-17
73233SUPPL2023-01-17
73174SUPPL2023-01-17
73173SUPPL2023-01-17
66455SUPPL2021-03-02
66448SUPPL2021-03-02
66190SUPPL2021-02-11
66189SUPPL2021-02-11
66131SUPPL2021-02-09
46632SUPPL2016-12-30
46465SUPPL2016-12-22
46243SUPPL2016-12-20
886SUPPL2011-08-26
11189SUPPL2011-08-24
33466SUPPL2011-06-07
885SUPPL2011-06-03
40793SUPPL2006-10-25
40792SUPPL2006-10-25
40791SUPPL2006-10-25
14963SUPPL2004-04-07
884SUPPL2004-04-07
20121SUPPL1997-11-20