FDA.reportPublic FDA data

Application 015197

Type
NDA
Sponsor
CLOVER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMICARAMINOCAPROIC ACIDTABLET;ORAL500MGYesNo
002AMICARAMINOCAPROIC ACIDTABLET;ORAL1GMYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-768Aminocaproic AcidAminocaproic AcidAkorn Inc.NDA AUTHORIZED GENERICCurrent
17478-768Aminocaproic AcidAminocaproic AcidAkorn Inc.NDA AUTHORIZED GENERICCurrent
17478-768Aminocaproic AcidAminocaproic AcidAkorn Operating Company LLCNDA AUTHORIZED GENERICCurrent
17478-769Aminocaproic AcidAminocaproic AcidAkorn Operating Company LLCNDA AUTHORIZED GENERICCurrent
17478-769Aminocaproic AcidAminocaproic AcidAkorn Inc.NDA AUTHORIZED GENERICCurrent
17478-769Aminocaproic AcidAminocaproic AcidAkorn Inc.NDA AUTHORIZED GENERICCurrent
49411-050AMICARAminocaproic AcidClover Pharmaceuticals Corp.NDACurrent
49411-050AMICARAminocaproic AcidAkorn Operating Company LLCNDACurrent
49411-050AMICARAminocaproic AcidClover Pharmaceuticals Corp.NDACurrent
49411-050AMICARAminocaproic AcidAkorn Operating Company LLCNDACurrent
49411-051AMICARAminocaproic AcidAkorn Operating Company LLCNDACurrent
49411-051AMICARAminocaproic AcidClover Pharmaceuticals Corp.NDACurrent
49411-051AMICARAminocaproic AcidClover Pharmaceuticals Corp.NDACurrent
49411-051AMICARAminocaproic AcidAkorn Operating Company LLCNDACurrent
61748-046Aminocaproic AcidAminocaproic AcidVersaPharm Inc - an Akorn CompanyNDA AUTHORIZED GENERICCurrent
61748-046Aminocaproic AcidAminocaproic AcidVersapharm IncorporatedNDA AUTHORIZED GENERICCurrent
68151-3023AMICARAminocaproic AcidCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10856SUPPL2008-08-26
12079SUPPL2008-08-22
12078SUPPL2004-08-25
33133SUPPL2004-06-25
33132SUPPL2004-06-25
33131SUPPL2004-06-25
12077SUPPL2004-06-25
10855SUPPL2004-06-25
397SUPPL2004-06-25
396SUPPL2004-06-25
395SUPPL2004-06-25