FDA.reportPublic FDA data

Application 021434

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XANAX XRALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL0.5MGYesNo
002XANAX XRALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL1MGYesNo
003XANAX XRALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL2MGYesNo
004XANAX XRALPRAZOLAMTABLET, EXTENDED RELEASE;ORAL3MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0057XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0057XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0057XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0057XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0057XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0057XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0059XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0059XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0059XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0059XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0059XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0059XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0066XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0066XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0066XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0066XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0066XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0066XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0068XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0068XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0068XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0068XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
0009-0068XanaxalprazolamPharmacia & Upjohn Company LLCNDACurrent
0009-0068XanaxalprazolamPharmacia and Upjohn Company LLCNDACurrent
35356-503AlprazolamalprazolamLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
35356-504AlprazolamalprazolamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
59762-0057AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0057AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0057AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0057AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0057AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0059AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0059AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0059AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0059AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0059AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0066AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0066AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0066AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0066AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0066AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0068AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0068AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0068AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0068AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0068AlprazolamalprazolamGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73418SUPPL 2023-02-08
73362SUPPL 2023-02-02
73356SUPPL 2023-02-01
73237SUPPL2023-01-17
66454SUPPL2021-03-02
66449SUPPL2021-03-02
66192SUPPL2021-02-11
66191SUPPL2021-02-11
66132SUPPL2021-02-09
46633SUPPL2016-12-30
46466SUPPL2016-12-22
46242SUPPL2016-12-20
5359SUPPL2011-08-26
15453SUPPL2011-08-24
15452SUPPL2011-06-07
5358SUPPL2011-06-03
42157SUPPL2006-10-25
42156ORIG2004-12-07
27760ORIG2004-06-30
27761SUPPL2004-04-07
36912ORIG2003-03-06