ANDA 204030, held by Aurobindo Pharma Ltd. Amoxicillin.
As of Nov 14, 2026, ANDA 204030 (Amoxicillin), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 15, 2014, with 5 approved supplements and 0 published complete response letters.
Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. Infections of the Genitourinary Tract: Amoxicillin for oral suspension is
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2014 | Original application | Approved | None posted |
| Amoxicillin125MG/5ML · for suspension;oral | Amoxicillin | Rx |
| Amoxicillin250MG/5ML · for suspension;oral | Amoxicillin | Rx |
| May 1, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 12, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 29, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 29, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 29, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 15, 2014 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
