FDA.reportPublic FDA data

Application 050725

Type
NDA
Sponsor
NEOPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AUGMENTIN '200'AMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL200MG/5ML;EQ 28.5MG BASE/5MLYesNo
002AUGMENTIN '400'AMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL400MG/5ML;EQ 57MG BASE/5MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-208amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-213amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
63187-320amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumProficient Rx LPNDACurrent
63187-320amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumProficient Rx LPNDACurrent
68788-9745amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
70518-2082AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.NDACurrent
70518-2082AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.NDACurrent
72508-204AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNeopharma IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78374SUPPL 2024-05-02
78367SUPPL 2024-05-02
71949SUPPL2022-08-29
71931SUPPL2022-08-26
30389SUPPL2013-01-24
30388SUPPL2013-01-24
18132SUPPL2013-01-23
18131SUPPL2013-01-23
8127SUPPL2011-10-04
18130SUPPL2011-09-30
30386SUPPL2008-12-11
18129SUPPL2008-12-08
30387SUPPL2008-04-02
39201SUPPL2008-03-27
42707SUPPL2006-10-25
42706SUPPL2006-10-25
42705SUPPL2006-10-25
42704SUPPL2006-10-25
42703SUPPL2006-10-25
42702SUPPL2006-10-25
42701SUPPL2006-10-25
42700SUPPL2006-10-25
22209SUPPL2006-10-25
22208SUPPL2006-10-25
22207SUPPL2006-10-25
22206SUPPL2006-10-25
22205SUPPL2006-10-25
8126SUPPL2004-08-12
8125SUPPL2004-06-07
30384SUPPL2004-05-27
30385SUPPL2003-06-08