FDA.report

Application 050755

Type
NDA
Sponsor
NEOPHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AUGMENTIN ES-600AMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL600MG/5ML;EQ 42.9MG BASE/5MLYesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-600Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumAidarex Pharmaceuticals LLCNDACurrent
33261-970Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumAidarex Pharmaceuticals LLCNDACurrent
43598-003AUGMENTIN ES-600amoxicillin and clavulanate potassiumDr Reddys Laboratories IncNDACurrent
68788-9310Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
68788-9847AMOXICILLIN AND CLAVULANATE POTASSIUMamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, IncNDACurrent
72508-203AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNeopharma IncNDACurrent
72508-203AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNeopharma IncNDACurrent
81964-003AUGMENTIN ES-600amoxicillin and clavulanate potassiumUSAntibiotics, LLCNDACurrent
81964-003AUGMENTIN ES-600amoxicillin and clavulanate potassiumUSAntibiotics, LLCNDACurrent
81964-203AMOXICILLIN AND CLAVULANATE POTASSIUMamoxicillin and clavulanate potassiumUSAntibiotics, LLCNDA AUTHORIZED GENERICCurrent
81964-203AMOXICILLIN AND CLAVULANATE POTASSIUMamoxicillin and clavulanate potassiumUSAntibiotics, LLCNDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
80737SUPPL 2024-12-26
80705SUPPL 2024-12-26
78378SUPPL 2024-05-03
78354SUPPL 2024-05-02
72148SUPPL2022-09-23
72145SUPPL2022-09-23
71523SUPPL2022-07-06
71503SUPPL2022-07-01
39265SUPPL2015-03-19
8200SUPPL2015-03-17
30459SUPPL2011-08-31
8199SUPPL2011-08-31
39264SUPPL2011-08-30
39263SUPPL2011-08-30
8197SUPPL2009-01-26
39262SUPPL2009-01-16
8198SUPPL2008-04-22
22222SUPPL2005-06-27
22223SUPPL2005-02-04
39261SUPPL2004-12-30
8196SUPPL2004-12-30
30458SUPPL2004-11-16
39260SUPPL2004-07-27
30457SUPPL2004-06-07
22221ORIG2004-05-27
30456SUPPL2003-06-08
39259ORIG2001-06-26
30455ORIG2001-06-26