Treats hypertension. ANDA 205231, held by Twi Pharms. Diltiazem Hydrochloride.
As of Nov 15, 2026, ANDA 205231 (Diltiazem Hydrochloride), held by Twi Pharms, was first approved by FDA on Aug 30, 2018, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2018 | Original application | Approved | None posted |
| Diltiazem Hydrochloride120MG · capsule, extended release;oral | Diltiazem Hydrochloride | Rx |
| Diltiazem Hydrochloride180MG · capsule, extended release;oral | Diltiazem Hydrochloride | Rx |
| Diltiazem Hydrochloride240MG · capsule, extended release;oral | Diltiazem Hydrochloride | Rx |
| Diltiazem Hydrochloride300MG · capsule, extended release;oral | Diltiazem Hydrochloride | Rx |
| Diltiazem Hydrochloride360MG · capsule, extended release;oral | Diltiazem Hydrochloride | Rx |
| Aug 12, 2026 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 12, 2026 | Supplement 22Labeling · Standard review | Approved | None posted |
| Aug 30, 2018 | 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
