ANDA 65056, held by Chartwell Rx. Amoxicillin.
As of Nov 14, 2026, ANDA 65056 (Amoxicillin), held by Chartwell Rx, was first approved by FDA on Sep 18, 2000, with 10 approved supplements and 0 published complete response letters.
Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are 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 tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2000 | Original application | Approved |
| Amoxicillin500MG · tablet;oral | Amoxicillin | Rx |
| Amoxicillin875MG · tablet;oral | Amoxicillin | Rx |
| May 1, 2024 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jan 3, 2024 | Supplement 21Labeling · Standard review | Approved | None posted |
| Oct 22, 2014 | Supplement 20Manufacturing | Approved | None posted |
| May 2, 2013 | Supplement 17Labeling | Approved | |
| Feb 25, 2009 | Supplement 14Labeling | Approved | None posted |
| Aug 20, 2002 | Supplement 5Manufacturing | Approved | None posted |
| Aug 20, 2002 | Supplement 6Manufacturing | Approved | None posted |
| Jun 28, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Oct 24, 2001 | Supplement 2Manufacturing | Approved | None posted |
| May 15, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Sep 18, 2000 | Original application | Approved |
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
