ANDA 210681, held by Novitium Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 210681 (Ranitidine Hydrochloride), held by Novitium Pharma, was first approved by FDA on Nov 23, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2018 | Original application | Approved | None posted |
| Ranitidine HydrochlorideEQ 150MG BASE · capsule;oral | Ranitidine Hydrochloride | Discontinued |
| Ranitidine HydrochlorideEQ 300MG BASE · capsule;oral | Ranitidine Hydrochloride | Discontinued |
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
