FDA.reportPublic FDA data

Application 050575

Type
NDA
Sponsor
NEOPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AUGMENTIN '125'AMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL125MG/5ML;EQ 31.25MG BASE/5MLYesNo
002AUGMENTIN '250'AMOXICILLIN; CLAVULANATE POTASSIUMFOR SUSPENSION;ORAL250MG/5ML;EQ 62.5MG BASE/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-282Amoxicillin and Clavulanate Potassiumamoxicillin and clavulanate potassiumRebel Distributors CorpNDACurrent
43598-004AUGMENTINamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-012AUGMENTINamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-204amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
72508-004AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent
72508-004AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent
72508-012AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent
72508-012AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent
72508-204AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNeopharma IncNDACurrent
72508-204AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNeopharma IncNDACurrent
72508-204AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNeopharma IncNDACurrent
81964-204AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumUSAntibiotics, LLCNDA AUTHORIZED GENERICCurrent
81964-212AMOXICILLIN AND CLAVULANATE POTASSIUMAmoxicillin and Clavulanate PotassiumUSAntibiotics, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78371SUPPL 2024-05-02
78364SUPPL 2024-05-02
71946SUPPL2022-08-29
71928SUPPL2022-08-26
7833SUPPL2013-01-24
7832SUPPL2013-01-24
38996SUPPL2013-01-23
17891SUPPL2013-01-23
30105SUPPL2011-10-04
17890SUPPL2011-09-30
30104SUPPL2008-12-11
17888SUPPL2008-12-08
7831SUPPL2008-04-02
17889SUPPL2008-03-27
7830SUPPL2004-08-12
30103SUPPL2004-06-07
30101SUPPL2004-05-27
30102SUPPL2003-06-08
22162SUPPL1999-08-02