Manages hypertension. ANDA 200645, held by Alembic Pharms Ltd. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 200645 (Hydrochlorothiazide), held by Alembic Pharms Ltd, was first approved by FDA on Nov 30, 2010, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrochlorothiazide capsules, USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide12.5MG · capsule;oral | Hydrochlorothiazide | Discontinued |
| Mar 21, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 17, 2011 | Supplement 1Labeling | Approved | None posted |
| Nov 30, 2010 | 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
