Home Applications 050575 Application 050575
Type NDA
Sponsor NEOPHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 125MG/5ML;EQ 31.25MG BASE/5ML Yes No 002 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION;ORAL 250MG/5ML;EQ 62.5MG BASE/5ML Yes Yes
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 N050575-001 AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 N050575-002 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06
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 2 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 2019-12-13 00:20 UTC 2019-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050575-001 AUGMENTIN '125' 125MG/5ML;EQ 31.25MG BASE/5ML FOR SUSPENSION / ORAL AB RLD 1984-08-06 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050575-002 AUGMENTIN '250' 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION / ORAL AB RLD, RS 1984-08-06 3a93d1ddd44b…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Augmentin AMOXICILLIN AND CLAVULANATE POTASSIUM Allegis Holdings, LLC 04a31a42-d79e-bbb4-e063-6394a90a63ee 2024-05-16 Warnings, Adverse reactions Exact identifier application applno (NDA): 050575 application number: NDA050575
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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42254-282 Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium Rebel Distributors Corp NDA Current 43598-004 AUGMENTIN amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 43598-012 AUGMENTIN amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 43598-204 amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 72508-004 AUGMENTIN amoxicillin and clavulanate potassium Neopharma Inc NDA Current 72508-004 AUGMENTIN amoxicillin and clavulanate potassium Neopharma Inc NDA Current 72508-012 AUGMENTIN amoxicillin and clavulanate potassium Neopharma Inc NDA Current 72508-012 AUGMENTIN amoxicillin and clavulanate potassium Neopharma Inc NDA Current 72508-204 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM Neopharma Inc NDA Current 72508-204 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM Neopharma Inc NDA Current 72508-204 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM Neopharma Inc NDA Current 81964-204 AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium USAntibiotics, LLC NDA AUTHORIZED GENERIC Current 81964-212 AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium USAntibiotics, LLC NDA AUTHORIZED GENERIC Current