ANDA 70543, held by Chartwell Rx. Hydrochlorothiazide; Methyldopa.
As of Nov 15, 2026, ANDA 70543 (Methyldopa And Hydrochlorothiazide), held by Chartwell Rx, was first approved by FDA on Jan 15, 1986, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methyldopa And Hydrochlorothiazide30MG;500MG · tablet;oral | Hydrochlorothiazide; Methyldopa | Discontinued |
| Aug 20, 2020 | Supplement 26Labeling · Standard review | Approved | None posted |
| Aug 6, 2020 | Supplement 25Labeling · Standard review | Approved | None posted |
| Nov 25, 1998 | Supplement 19Manufacturing | Approved | None posted |
| Nov 25, 1998 | Supplement 20Manufacturing | Approved | None posted |
| Aug 19, 1996 | Supplement 16Manufacturing | Approved | None posted |
| Apr 2, 1996 | Supplement 17Labeling | Approved | None posted |
| Jan 24, 1994 | Supplement 15Manufacturing | Approved | None posted |
| Aug 2, 1993 | Supplement 14Labeling | Approved | None posted |
| Apr 30, 1993 | Supplement 13Labeling | Approved | None posted |
| Jan 31, 1992 | Supplement 12Labeling | Approved | None posted |
| Dec 12, 1989 | Supplement 11Manufacturing | Approved | None posted |
| Sep 15, 1989 | Supplement 10Labeling | Approved | None posted |
| Jan 29, 1988 | Supplement 6Manufacturing | Approved | None posted |
| Dec 22, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Dec 4, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Dec 4, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Jan 15, 1986 | 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
