FDA.report

Application 050720

Type
NDA
Sponsor
NEOPHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AUGMENTIN '875'AMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL875MG;EQ 125MG BASEYesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-021AUGMENTINamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-221amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
68071-2431Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.NDACurrent
68071-2448Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.NDACurrent
68071-2475Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.NDACurrent
68071-3250amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals, Inc.NDACurrent
68071-3302amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumNuCare Pharmaceuticals, Inc.NDACurrent
68788-8307AMOXICILLIN AND CLAVULANATE POTASSIUMamoxicillin and clavulanate potassiumPreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-9961amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
68788-9961amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
68788-9961amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
72508-021AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent
72508-221Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNeopharma IncNDACurrent
72508-221Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNeopharma IncNDACurrent
72789-076Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-076Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-076Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
72789-083Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.NDACurrent
81964-221AMOXICILLIN AND CLAVULANATE POTASSIUMamoxicillin and clavulanate potassiumUSAntibiotics, LLCNDA AUTHORIZED GENERICCurrent
81964-221AMOXICILLIN AND CLAVULANATE POTASSIUMamoxicillin and clavulanate potassiumUSAntibiotics, LLCNDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
78373SUPPL 2024-05-02
78366SUPPL 2024-05-02
71948SUPPL2022-08-29
71930SUPPL2022-08-26
8106SUPPL2013-01-24
8105SUPPL2013-01-24
39183SUPPL2013-01-23
18113SUPPL2013-01-23
8104SUPPL2011-10-03
18112SUPPL2011-09-30
30364SUPPL2008-12-11
18111SUPPL2008-12-08
8102SUPPL2008-06-13
39181SUPPL2008-06-12
39182SUPPL2008-04-16
8103SUPPL2008-04-10
30363SUPPL2005-08-11
42696SUPPL2004-11-22
42695SUPPL2004-11-22
42694SUPPL2004-11-22
42693SUPPL2004-11-22
42692SUPPL2004-11-22
42691SUPPL2004-11-22
42690SUPPL2004-11-22
42689SUPPL2004-11-22
22199SUPPL2004-11-22
22198SUPPL2004-11-22
22197SUPPL2004-11-22
22196SUPPL2004-11-22
22195SUPPL2004-11-22
8101SUPPL2004-09-03
30362SUPPL2004-06-01
8099SUPPL2004-05-27
8100SUPPL2003-08-15