ANDA 65412, held by Yung Shin Pharm. Cefaclor.
As of Nov 13, 2026, ANDA 65412 (Cefaclor), held by Yung Shin Pharm, was first approved by FDA on Feb 17, 2012, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2012 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2024 | Supplement 7Manufacturing | Approved | None posted |
| Oct 14, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 17, 2012 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
