Home Applications 065098 Application 065098
Type ANDA
Sponsor SANDOZ INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 200MG/5ML;EQ 28.5MG BASE/5ML No No 002 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 400MG/5ML;EQ 57MG BASE/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065098-001 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 A065098-002 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A065098-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A065098-002 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065098-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 e64feba35796…2022-09-29 23:25 UTC 2022-09 A065098-002 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065098-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065098-002 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A065098-001 AMOXICILLIN AND CLAVULANATE POTASSIUM 200MG/5ML;EQ 28.5MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A065098-002 AMOXICILLIN AND CLAVULANATE POTASSIUM 400MG/5ML;EQ 57MG BASE/5ML FOR SUSPENSION / ORAL AB 2002-12-16 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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.
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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45865-927 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium medsource pharmaceuticals ANDA Current 53002-0050 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium RPK Pharmaceuticals, Inc. ANDA Current 53002-0050 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium RPK Pharmaceuticals, Inc. ANDA Current 63187-542 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Proficient Rx LP ANDA Current 63187-542 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Proficient Rx LP ANDA Current 66685-1011 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Sandoz Inc ANDA Current 66685-1011 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Sandoz Inc ANDA Current 66685-1011 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Sandoz Inc ANDA Current 66685-1012 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Sandoz Inc ANDA Current 66685-1012 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Sandoz Inc ANDA Current 66685-1012 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Sandoz Inc ANDA Current 68071-4145 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium NuCare Pharmaceuticals,Inc. ANDA Current 68788-8996 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals Inc. ANDA Current 68788-8996 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals Inc. ANDA Current 68788-8996 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals Inc. ANDA Current 68788-9424 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals, Inc. ANDA Current 68788-9424 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals, Inc. ANDA Current 68788-9424 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals, Inc. ANDA Current