Regulatory Updates

FDA records show that MPP Pharma's ANDA076486 for two oral enalapril maleate/hydrochlorothiazide tablets received multiple labeling approvals, but both products are listed as discontinued.

The FDA approved ANDA209242 for Camber’s prescription oral tablet combining olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in multiple strengths.

The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.

FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.

FDA records multiple labeling submissions for Teva’s discontinued oral tablet combining amlodipine besylate, valsartan, and hydrochlorothiazide (ANDA 200435). All listed product variants are marked discontinued.

The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.

FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.

The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.

The FDA granted original approval for ANDA081189, a 25 mg oral Hydrochlorothiazide tablet from Watson Labs, with multiple labeling supplements approved through 1995. The product is now discontinued.

The FDA approved ANDA 085208 for a 50 mg oral tablet of hydrochlorothiazide, now marked as discontinued, with supplemental manufacturing and labeling approvals spanning 1981‑2020.

FDA records show four oral tablet products of benazepril hydrochloride and hydrochlorothiazide under ANDA077483 are discontinued, with multiple supplemental labeling approvals.

FDA has approved ANDA083666 submitted by Watson Labs for an oral tablet combining 50 mg hydrochlorothiazide and 0.125 mg reserpine; the product is listed as discontinued.