Application 011792

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOMACARISOPRODOLTABLET;ORAL350MGYesNo
003SOMACARISOPRODOLCAPSULE;ORAL250MGYesNo
004SOMACARISOPRODOLTABLET;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-2001SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2001SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2001SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2001SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2250SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2250SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2250SomaCarisoprodolMeda PharmaceuticalsNDACurrent
0037-2250SomaCarisoprodolMeda PharmaceuticalsNDACurrent
21695-606SomaCarisoprodolRebel Distributors CorpNDACurrent
51525-5901CarisoprodolcarisoprodolWallace Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
51525-5901CarisoprodolcarisoprodolWallace Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
51525-5901CarisoprodolcarisoprodolWallace Pharmaceuticals INDA AUTHORIZED Current
51525-5901CarisoprodolcarisoprodolWallace Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58232SUPPL2019-04-05
58223SUPPL2019-04-05
55272SUPPL2018-08-23
11962SUPPL2015-02-25
33058SUPPL2013-02-06
287SUPPL2013-02-04
20030SUPPL2012-11-16
11961SUPPL2010-01-06
33057SUPPL2009-11-17
11960SUPPL2007-09-25
33056SUPPL2007-09-19
10780SUPPL2006-06-12
286SUPPL2006-06-12