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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050725-001AUGMENTIN '200'AMOXICILLIN; CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31
N050725-002AUGMENTIN '400'AMOXICILLIN; CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3184e616aacf4f…
2026-09-14 22:38:342026-08N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3184e616aacf4f…
2026-08-18 06:07:402026-07N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050725-001AUGMENTIN '200'200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050725-002AUGMENTIN '400'400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALRLD1996-05-3174a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP1f252ad3-373c-4a6d-96e7-53ba820d201b2019-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 050725
application number: NDA050725
ndc (product): 63187-320

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

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