ANDA 74655, held by Sandoz. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 74655 (Ranitidine Hydrochloride), held by Sandoz, was first approved by FDA on Oct 22, 1997, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 1997 | Original application | Approved |
| Ranitidine HydrochlorideEQ 150MG BASE · capsule;oral | Ranitidine Hydrochloride | Rx |
| Ranitidine HydrochlorideEQ 300MG BASE · capsule;oral | Ranitidine Hydrochloride | Rx |
| Feb 7, 2013 | Supplement 35Labeling | Approved | None posted |
| May 27, 2009 | Supplement 34Labeling | Approved | None posted |
| Dec 26, 2007 | Supplement 28Labeling | Approved | None posted |
| Apr 28, 2005 | Supplement 23Labeling | Approved | None posted |
| Mar 12, 2004 | Supplement 17Labeling | Approved | None posted |
| Apr 19, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Nov 6, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Mar 19, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Jan 26, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Nov 30, 2000 | Supplement 7Manufacturing | Approved | None posted |
| May 25, 2000 | Supplement 6Labeling | Approved | None posted |
| Mar 3, 2000 | Supplement 5Labeling | Approved | None posted |
| Feb 2, 2000 | Supplement 4Manufacturing | Approved | None posted |
| Aug 9, 1999 | Supplement 3Manufacturing | Approved | None posted |
| May 20, 1998 | Supplement 1Manufacturing | Approved | None posted |
| May 20, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Oct 22, 1997 | 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
