FDA.reportPublic FDA data

Application 065189

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL250MG;EQ 125MG BASENoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065189-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM250MG;EQ 125MG BASETABLET / ORALABRS2005-08-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A065189-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065189-001AMOXICILLIN AND CLAVULANATE POTASSIUM250MG;EQ 125MG BASETABLET / ORALABRS2005-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065189-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Inc7cba82f0-9886-46e9-8dbd-43a448aade292025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065189
application number: ANDA065189
ndc (product): 0781-1874
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.a94cfba3-27ed-46a3-81ef-e9b80187c2072024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065189
application number: ANDA065189
ndc (product): 76420-503

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1874Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-476Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
43858-607Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-607Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
53808-0759Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMState of Florida DOH Central PharmacyANDACurrent
70882-111Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumCambridge Therapeutics Technologies, LLCANDACurrent
76420-503Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22319ORIG2008-07-31