ANDA 75565, held by Pharm Assoc. Loratadine.
As of Nov 14, 2026, ANDA 75565 (Loratadine), held by Pharm Assoc, was first approved by FDA on Oct 5, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 2004 | Original application | Approved | None posted |
| Loratadine1MG/ML · syrup;oral | Loratadine | Discontinued |
| Loratadine5MG/5ML · syrup; oral | Loratadine | OTC |
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
