Treats hypertension. ANDA 90421, held by Sun Pharm. Diltiazem Hydrochloride.
As of Nov 15, 2026, ANDA 90421 (Diltiazem Hydrochloride), held by Sun Pharm, was first approved by FDA on Nov 15, 2010, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension: Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina: Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2010 | Original application | Approved | None posted |
| Diltiazem Hydrochloride120MG · capsule, extended release;oral | Diltiazem Hydrochloride | Discontinued |
| Diltiazem Hydrochloride180MG · capsule, extended release;oral | Diltiazem Hydrochloride | Discontinued |
| Diltiazem Hydrochloride240MG · capsule, extended release;oral | Diltiazem Hydrochloride | Discontinued |
| Diltiazem Hydrochloride300MG · capsule, extended release;oral | Diltiazem Hydrochloride | Discontinued |
| Diltiazem Hydrochloride360MG · capsule, extended release;oral | Diltiazem Hydrochloride | Discontinued |
| Mar 3, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 3, 2025 | Supplement 21Labeling · Standard review | Approved | None posted |
| Mar 3, 2025 | Supplement 23Labeling · Standard review | Approved | None posted |
| Aug 24, 2012 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 15, 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
