ANDA 70614, held by Strides Pharma Intl. Hydrochlorothiazide; Methyldopa.
As of Nov 15, 2026, ANDA 70614 (Methyldopa And Hydrochlorothiazide), held by Strides Pharma Intl, was first approved by FDA on Feb 2, 1987, with 25 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 1987 | Original application | Approved | None posted |
| Methyldopa And Hydrochlorothiazide50MG;500MG · tablet;oral | Hydrochlorothiazide; Methyldopa | Discontinued |
| Methyldopa And Hydrochlorothiazide15MG;250MG · tablet;oral | Hydrochlorothiazide; Methyldopa | Discontinued |
| Methyldopa And Hydrochlorothiazide25MG;250MG · tablet;oral | Hydrochlorothiazide; Methyldopa | Discontinued |
| Methyldopa And Hydrochlorothiazide30MG;500MG · tablet;oral | Hydrochlorothiazide; Methyldopa | Discontinued |
| Aug 20, 2020 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jan 21, 1998 | Supplement 26Manufacturing | Approved | None posted |
| Jul 30, 1997 | Supplement 18Manufacturing | Approved | None posted |
| Jul 30, 1997 | Supplement 17Manufacturing | Approved | None posted |
| Jul 30, 1997 | Supplement 16Manufacturing | Approved | None posted |
| Jul 30, 1997 | Supplement 15Manufacturing | Approved | None posted |
| Jun 6, 1996 | Supplement 25Labeling | Approved | None posted |
| Jan 27, 1994 | Supplement 24Labeling | Approved | None posted |
| Dec 22, 1993 | Supplement 19Manufacturing | Approved | None posted |
| Jul 2, 1993 | Supplement 23Labeling | Approved | None posted |
| Jul 29, 1992 | Supplement 22Labeling | Approved | None posted |
| Jun 9, 1992 | Supplement 21Labeling | Approved | None posted |
| Jan 17, 1989 | Supplement 14Labeling | Approved | None posted |
| Aug 18, 1988 | Supplement 13Labeling | Approved | None posted |
| Mar 24, 1988 | Supplement 9Manufacturing | Approved | None posted |
| Feb 4, 1988 | Supplement 10Manufacturing | Approved | None posted |
| Jan 22, 1988 | Supplement 12Labeling | Approved | None posted |
| Oct 14, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Oct 13, 1987 | Supplement 8Manufacturing | Approved | None posted |
| Oct 13, 1987 | Supplement 6Manufacturing | Approved | None posted |
| Sep 29, 1987 | Supplement 5Manufacturing | Approved | None posted |
| Sep 29, 1987 | Supplement 4Manufacturing | Approved | None posted |
| Sep 29, 1987 | Supplement 3Labeling | Approved | None posted |
| Aug 6, 1987 | Supplement 2Manufacturing | Approved | None posted |
| May 28, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Feb 2, 1987 | 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
