FDA.reportPublic FDA data

Application 050564

Type
NDA
Sponsor
NEOPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AUGMENTIN '250'AMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002AUGMENTIN '500'AMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-006AUGMENTINamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-018AUGMENTINamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-206amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
43598-218amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumDr. Reddy's Laboratories IncNDACurrent
68788-9960amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
68788-9960amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
68788-9960amoxicillin and clavulanate potassiumamoxicillin and clavulanate potassiumPreferred Pharmaceuticals, Inc.NDACurrent
72508-006AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent
72508-018AUGMENTINamoxicillin and clavulanate potassiumNeopharma IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78370SUPPL 2024-05-02
78363SUPPL 2024-05-02
71945SUPPL2022-08-29
71927SUPPL2022-08-26
30087SUPPL2013-01-24
7820SUPPL2013-01-24
17877SUPPL2013-01-23
17876SUPPL2013-01-23
30086SUPPL2011-10-03
17875SUPPL2011-09-30
30084SUPPL2008-12-11
38982SUPPL2008-12-08
7819SUPPL2008-06-13
17874SUPPL2008-06-12
30085SUPPL2008-04-02
38983SUPPL2008-03-27
7818SUPPL2005-08-11
7817SUPPL2004-09-03
30083SUPPL2004-06-01
30082SUPPL2004-05-27
7816SUPPL2003-08-15
22161SUPPL1999-08-02