FDA.reportPublic FDA data

Application 019787

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORVASCAMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASEYesNo
002NORVASCAMLODIPINE BESYLATETABLET;ORALEQ 5MG BASEYesNo
003NORVASCAMLODIPINE BESYLATETABLET;ORALEQ 10MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-1520Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1520Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1530Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1530Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1540Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
0069-1540Norvascamlodipine besylatePfizer Laboratories Div Pfizer IncNDACurrent
21695-151Norvascamlodipine besylateRebel Distributors CorpNDACurrent
55154-0535amlodipine besylateamlodipine besylateCardinal HealthNDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-103Norvascamlodipine besylatePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1520amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1530amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1540amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2010amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2135amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2242amlodipine besylateamlodipine besylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
67046-020amlodipine besylateamlodipine besylateContract Pharmacy Services-PANDA AUTHORIZED GENERICCurrent
67296-0672amlodipine besylateamlodipine besylateRedPharm Drug Inc.NDA AUTHORIZED GENERICCurrent
67296-0673amlodipine besylateamlodipine besylateRedPharm Drug Inc.NDA AUTHORIZED GENERICCurrent
69189-1540amlodipine besylateamlodipine besylateAvera McKennan HospitalNDA AUTHORIZED GENERICCurrent
71610-469amlodipine besylateamlodipine besylateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
71610-469amlodipine besylateamlodipine besylateAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50438SUPPL2017-11-17
50296SUPPL2017-11-06
47825SUPPL2017-04-03
47800SUPPL2017-03-31
11721SUPPL2015-04-09
19224SUPPL2015-03-25
19223SUPPL2013-01-08
19222SUPPL2013-01-08
11720SUPPL2013-01-07
11719SUPPL2013-01-07
19221SUPPL2011-11-02
11718SUPPL2011-10-31
1623SUPPL2011-05-11
33954SUPPL2011-05-09
33953SUPPL2010-02-23
19220SUPPL2010-02-22
1622SUPPL2007-11-08
11717SUPPL2007-11-07
41035SUPPL2007-03-02
19219SUPPL2005-10-20
33952SUPPL2005-09-30
33951SUPPL2005-07-15
1621SUPPL2005-07-15
1617SUPPL2004-06-10
1619SUPPL2004-01-09
19217SUPPL2003-12-08
1620SUPPL2003-08-28
41032SUPPL2003-08-05
41031SUPPL2003-08-05
41030SUPPL2003-08-05
41029SUPPL2003-08-05
41028SUPPL2003-08-05
41026SUPPL2003-08-05
41025SUPPL2003-08-05
41024SUPPL2003-08-05
20358SUPPL2003-08-05
20356SUPPL2003-08-05
20354SUPPL2003-08-05
20353SUPPL2003-08-05
20352SUPPL2003-08-05
20351SUPPL2003-08-05
19218SUPPL2002-05-28
41027SUPPL2002-04-30
41034SUPPL2000-07-12
20357SUPPL2000-07-12
1618SUPPL2000-07-12
1616SUPPL2000-07-12
20359SUPPL2000-02-01
20360SUPPL1999-12-15
41033SUPPL1999-06-04
20355SUPPL1997-01-08