ANDA 200821, held by Macleods Pharms Ltd. Pantoprazole Sodium.
As of Nov 15, 2026, ANDA 200821 (Pantoprazole Sodium), held by Macleods Pharms Ltd, was first approved by FDA on Feb 16, 2012, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2012 | Original application | Approved | None posted |
| Pantoprazole SodiumEQ 20MG BASE · tablet, delayed release;oral | Pantoprazole Sodium | Discontinued |
| Pantoprazole SodiumEQ 40MG BASE · tablet, delayed release;oral | Pantoprazole Sodium | Discontinued |
| Aug 30, 2024 | Supplement 23Labeling · Standard review | Approved | None posted |
| Aug 30, 2024 | Supplement 26Labeling · Standard review | Approved | None posted |
| Aug 30, 2024 | Supplement 27Labeling · Standard review | Approved | None posted |
| Aug 30, 2024 | Supplement 33Labeling · Standard review | Approved | None posted |
| Sep 13, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 13, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 13, 2019 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 13, 2019 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 13, 2019 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 23, 2016 | Supplement 7Manufacturing | Approved | None posted |
| Apr 9, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 12, 2013 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 12, 2013 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 16, 2012 | 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
