Home Applications 050564 Application 050564
Type NDA
Sponsor NEOPHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM TABLET;ORAL 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 AUGMENTIN '500' AMOXICILLIN; CLAVULANATE POTASSIUM TABLET;ORAL 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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 N050564-001 AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 N050564-002 AUGMENTIN '500' AMOXICILLIN; CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06
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 N050564-001 AUGMENTIN '250' 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050564-002 AUGMENTIN '500' 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050564-001 AUGMENTIN '250' 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050564-002 AUGMENTIN '500' 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050564-001 AUGMENTIN '250' 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050564-002 AUGMENTIN '500' 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050564-001 AUGMENTIN '250' 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050564-002 AUGMENTIN '500' 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-08-06 a50c72e98297…
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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43598-006 AUGMENTIN amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 43598-018 AUGMENTIN amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 43598-206 amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 43598-218 amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium Dr. Reddy's Laboratories Inc NDA Current 68788-9960 amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals, Inc. NDA Current 68788-9960 amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals, Inc. NDA Current 68788-9960 amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium Preferred Pharmaceuticals, Inc. NDA Current 72508-006 AUGMENTIN amoxicillin and clavulanate potassium Neopharma Inc NDA Current 72508-018 AUGMENTIN amoxicillin and clavulanate potassium Neopharma Inc NDA Current