FDA.reportPublic FDA data

Application 021774

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMBIEN CRZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL12.5MGYesYes
002AMBIEN CRZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL6.25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5501Ambienzolpidem tartratesanofi-aventis U.S. LLCNDACurrent
0024-5501Ambienzolpidem tartrateSanofi-Aventis U.S. LLCNDACurrent
0024-5501Ambienzolpidem tartrateSanofi-Aventis U.S. LLCNDACurrent
0024-5501Ambienzolpidem tartratesanofi-aventis U.S. LLCNDACurrent
0024-5501Ambienzolpidem tartrateSanofi-Aventis U.S. LLCNDACurrent
0024-5501Ambienzolpidem tartratesanofi-aventis U.S. LLCNDACurrent
0024-5521Ambienzolpidem tartrateSanofi-Aventis U.S. LLCNDACurrent
0024-5521Ambienzolpidem tartratesanofi-aventis U.S. LLCNDACurrent
0024-5521Ambienzolpidem tartrateSanofi-Aventis U.S. LLCNDACurrent
0024-5521Ambienzolpidem tartratesanofi-aventis U.S. LLCNDACurrent
0024-5521Ambienzolpidem tartratesanofi-aventis U.S. LLCNDACurrent
0024-5521Ambienzolpidem tartrateSanofi-Aventis U.S. LLCNDACurrent
0955-1702Zolpidem Tartratezolpidem tartrateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1702Zolpidem Tartratezolpidem tartrateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1702Zolpidem Tartratezolpidem tartrateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1702Zolpidem Tartratezolpidem tartrateWinthrop U.S, a business of sanofi-aventis U.S. LLCNDA AUTHORIZED GENERICCurrent
0955-1703Zolpidem Tartratezolpidem tartrateWinthrop U.S, a business of sanofi-aventis U.S. LLCNDA AUTHORIZED GENERICCurrent
0955-1703Zolpidem Tartratezolpidem tartrateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1703Zolpidem Tartratezolpidem tartrateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1703Zolpidem Tartratezolpidem tartrateWinthrop U.S.NDA AUTHORIZED GENERICCurrent
21695-213Ambien CRzolpidem tartrateRebel Distributors Corp.NDACurrent
21695-319Ambien CRzolpidem tartrateRebel Distributors Corp.NDACurrent
43353-727Zolpidem Tartratezolpidem tartrateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-727Zolpidem Tartratezolpidem tartrateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
49999-763Ambienzolpidem tartrateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
55289-205Ambienzolpidem tartratePD-Rx Pharmaceuticals, InNDACurrent
55289-205Ambienzolpidem tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-205Ambienzolpidem tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-205Ambienzolpidem tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-205Ambienzolpidem tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-205Ambienzolpidem tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
60760-703Zolpidem Tartratezolpidem tartrateSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
61919-348ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXNDACurrent
63187-862Zolpidem Tartratezolpidem tartrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-862Zolpidem Tartratezolpidem tartrateProficient Rx LPNDA AUTHORIZED GENERICCurrent
63629-3141Ambien CRzolpidem tartrateBryant Ranch PrepackNDACurrent
68071-4089Zolpidem Tartratezolpidem tartrateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68788-7182Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7182Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7407Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7407Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7407Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7407Zolpidem Tartratezolpidem tartratePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70262SUPPL2022-02-25
70261SUPPL2022-02-25
70260SUPPL2022-02-25
70259SUPPL2022-02-25
70248SUPPL2022-02-24
70247SUPPL2022-02-24
70246SUPPL2022-02-24
59778SUPPL2019-08-20
59777SUPPL2019-08-20
59759SUPPL2019-08-20
57599SUPPL2019-02-14
57482SUPPL2019-02-07
55513SUPPL2018-09-18
55501SUPPL2018-09-18
48860SUPPL2017-06-29
47499SUPPL2017-03-08
47472SUPPL2017-03-06
46052SUPPL2016-12-06
46023SUPPL2016-12-05
45055SUPPL2016-08-12
45056SUPPL2016-08-11
37621SUPPL2014-10-09
6158SUPPL2014-10-09
21813SUPPL2013-09-30
21812SUPPL2013-09-30
28574SUPPL2013-04-24
6157SUPPL2013-04-24
16352SUPPL2013-04-23
16351SUPPL2013-04-23
37620SUPPL2010-04-19
6156SUPPL2010-04-19
28573SUPPL2008-01-09
28572SUPPL2008-01-09
28571SUPPL2008-01-09
6155SUPPL2008-01-09
6154SUPPL2008-01-09
37619SUPPL2008-01-08
37618SUPPL2008-01-08
16350SUPPL2008-01-08
16349SUPPL2008-01-08
16348SUPPL2008-01-08
23675ORIG2007-03-16
21811ORIG2006-06-07
16347ORIG2005-09-08
6153ORIG2005-09-08