FDA.reportPublic FDA data

Application 020835

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTONELRISEDRONATE SODIUMTABLET;ORAL30MGYesNo
002ACTONELRISEDRONATE SODIUMTABLET;ORAL5MGYesNo
003ACTONELRISEDRONATE SODIUMTABLET;ORAL35MGYesYes
004ACTONELRISEDRONATE SODIUMTABLET;ORAL75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005ACTONELRISEDRONATE SODIUMTABLET;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0149-0470ACTONELRISEDRONATE SODIUMWarner Chilcott Pharmaceuticals Inc.NDACurrent
0149-0471ACTONELRISEDRONATE SODIUMWarner Chilcott Pharmaceuticals Inc.NDACurrent
0149-0472ACTONELRISEDRONATE SODIUMWarner Chilcott Pharmaceuticals Inc.NDACurrent
0149-0478ACTONELRISEDRONATE SODIUMWarner Chilcott Pharmaceuticals Inc.NDACurrent
0430-0470ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0470ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0470ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0471ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0471ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0471ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0472ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0430-0478ActonelRisedronate SodiumAllergan, Inc.NDACurrent
0591-2044risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2044risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2044risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2044risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2067risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2067risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2067risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2067risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2075risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2075risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2075risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2075risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2075risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2102risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2102risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2102risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2109risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2109risedronate sodiumrisedronate sodiumActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
59762-0405Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0405Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0405Risedronate SodiumRisedronate SodiumGreenstone LLCNDACurrent
59762-0405Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0405Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0406Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0406Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0406Risedronate SodiumRisedronate SodiumGreenstone LLCNDACurrent
59762-0406Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0406Risedronate SodiumRisedronate SodiumGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84937SUPPL 2026-02-05
84913SUPPL 2026-02-05
84938SUPPL 2026-02-03
61479SUPPL2019-12-31
61478SUPPL2019-12-31
60791SUPPL2019-11-07
46085SUPPL2016-12-07
26005SUPPL2015-04-13
35476SUPPL2015-04-10
13567SUPPL2015-03-27
3518SUPPL2015-03-27
13566SUPPL2013-04-23
3517SUPPL2013-04-23
3516SUPPL2011-08-24
26004SUPPL2011-02-02
3515SUPPL2011-02-02
35475SUPPL2011-01-31
13565SUPPL2011-01-31
26003SUPPL2010-01-06
13564SUPPL2010-01-04
26002SUPPL2009-07-31
13563SUPPL2009-07-30
53398ORIG2009-04-24
53397ORIG2009-04-24
51086SUPPL2009-04-24
23604ORIG2009-04-24
26001SUPPL2008-04-25
3514SUPPL2008-04-25
20998SUPPL2008-02-19
20997SUPPL2008-02-19
20996SUPPL2008-02-19
41742SUPPL2007-07-27
13562SUPPL2007-07-27
3513SUPPL2007-07-27
13561SUPPL2007-04-20
3512SUPPL2007-04-20
26000SUPPL2006-08-21
3511SUPPL2006-08-21
35474SUPPL2006-08-14
13560SUPPL2006-08-14
3509SUPPL2006-01-30
35472SUPPL2006-01-25
35473SUPPL2005-09-15
3510SUPPL2005-09-15
35471SUPPL2005-05-17
25999SUPPL2005-05-17
41739ORIG2004-05-25
13559SUPPL2004-04-05
3508SUPPL2004-02-25
35470SUPPL2003-05-20
25998SUPPL2002-05-17
3507SUPPL2002-05-17
41741SUPPL2001-08-17
41740SUPPL2001-08-17
20995SUPPL2001-08-17
20994SUPPL2001-08-17
35469SUPPL2000-04-14
25997SUPPL2000-04-14
25996SUPPL2000-04-14
13558SUPPL2000-04-14
13557SUPPL2000-04-14
13556SUPPL2000-04-14
3506SUPPL2000-04-14
3505SUPPL2000-04-14
3504ORIG1998-03-27
64069ORIG1900-01-01
64068ORIG1900-01-01
64067ORIG1900-01-01
54082SUPPL1900-01-01
54081SUPPL1900-01-01