FDA.reportPublic FDA data

Application 019183

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARAFATESUCRALFATESUSPENSION;ORAL1GM/10MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0747SucralfateSucralfatePharmaceutical Associates, Inc.NDACurrent
0121-0747SucralfateSucralfatePharmaceutical Associates, Inc.NDACurrent
0121-0747SucralfateSucralfatePharmaceutical Associates, Inc.NDACurrent
0254-1011SucralfateSucralfatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-1011SucralfateSucralfatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
17856-0170CarafateSucralfateAtlantic Biologicals CorpsNDACurrent
17856-0170CarafateSucralfateAtlantic Biologicals CorpsNDACurrent
17856-0170CarafateSucralfateATLANTIC BIOLOGICALS CORP.NDACurrent
17856-1011SucralfateSucralfateATLANTIC BIOLOGICALS CORP.NDA AUTHORIZED GENERICCurrent
17856-1011SucralfateSucralfateATLANTIC BIOLOGICALS CORP.NDA AUTHORIZED GENERICCurrent
55154-4057SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal Health 107, LLCNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
55154-5778SucralfateSucralfateCardinal HealthNDACurrent
58914-170CarafateSucralfateAllergan, Inc.NDACurrent
58914-170CarafateSucralfateAllergan, Inc.NDACurrent
58914-170CarafateSucralfateAllergan, Inc.NDACurrent
66689-790SucralfateSucralfateVistaPharm, Inc.NDACurrent
66689-790SucralfateSucralfateVistaPharm, Inc.NDACurrent
66689-790SucralfateSucralfateVistaPharm, Inc.NDACurrent
66689-790SucralfateSucralfateVistaPharm, Inc.NDACurrent
66689-790SucralfateSucralfateVistaPharm, Inc.NDACurrent
66689-790SucralfateSucralfateVistaPharm, Inc.NDACurrent
68094-043SucralfateSucralfatePrecision Dose, Inc.NDA AUTHORIZED GENERICCurrent
68094-043SucralfateSucralfatePrecision Dose, Inc.NDA AUTHORIZED GENERICCurrent
68094-043SucralfateSucralfatePrecision Dose, Inc.NDA AUTHORIZED GENERICCurrent
68094-171SucralfateSucralfatePrecision Dose Inc.NDACurrent
68094-171SucralfateSucralfatePrecision Dose Inc.NDACurrent
68094-171SucralfateSucralfatePrecision Dose Inc.NDACurrent
69339-148SucralfateSucralfateDash Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69339-148SucralfateSucralfateDash Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69339-148SucralfateSucralfateDash Pharmaceuticals LLCNDACurrent
81646-101SucralfateSucralfatePINNACLE PHARMA LLCNDA AUTHORIZED GENERICCurrent
81646-101SucralfateSucralfatePINNACLE PHARMA LLCNDA AUTHORIZED GENERICCurrent
81646-1011SucralfateSucralfatePINNACLE PHARMA LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74238SUPPL 2023-05-15
74237SUPPL 2023-05-15
49489SUPPL2017-08-21
49428SUPPL2017-08-16
11446SUPPL2013-03-08
1246SUPPL2013-03-05
40878ORIG2011-02-15
16210SUPPL2010-12-28
11445SUPPL2010-12-26
16209SUPPL2007-05-01
11444SUPPL2007-05-01
16208SUPPL2006-02-22