FDA.reportPublic FDA data

Application 015230

Type
NDA
Sponsor
CLOVER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AMICARAMINOCAPROIC ACIDSYRUP;ORAL1.25GM/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-447Aminocaproic AcidAminocaproic AcidAkorn Operating Company LLCNDA AUTHORIZED GENERICCurrent
17478-447Aminocaproic AcidAminocaproic AcidAkorn Inc.NDA AUTHORIZED GENERICCurrent
17478-447Aminocaproic AcidAminocaproic AcidAkorn Inc.NDA AUTHORIZED GENERICCurrent
49411-052AMICARAminocaproic AcidAkorn Operating Company LLCNDACurrent
49411-052AMICARAminocaproic AcidClover Pharmaceuticals Corp.NDACurrent
49411-052AMICARAminocaproic AcidClover Pharmaceuticals Corp.NDACurrent
49411-052AMICARAminocaproic AcidAkorn Operating Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12957SUPPL2009-02-13
10858SUPPL2009-02-04
10857SUPPL2008-08-26
400SUPPL2008-08-22
399SUPPL2004-08-25
12956SUPPL2003-09-09
12955SUPPL2003-09-09
398SUPPL2003-09-09