Treats infections caused by susceptible strains of the designated organisms listed below. ANDA 216554, held by Aurobindo Pharma. Ampicillin/Ampicillin Trihydrate.
As of Nov 15, 2026, ANDA 216554 (Ampicillin Trihydrate), held by Aurobindo Pharma, was first approved by FDA on Oct 31, 2023, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules and other antibacterial drugs, ampicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2023 | Original application | Approved | None posted |
| Ampicillin TrihydrateEQ 250MG BASE · capsule;oral | Ampicillin/Ampicillin Trihydrate | Rx |
| Ampicillin TrihydrateEQ 500MG BASE · capsule;oral | Ampicillin/Ampicillin Trihydrate | Rx |
| May 1, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 31, 2023 | 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
