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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

#hydrochlorothiazide ×

UPDATED
규제 업데이트
2026년 9월 25일•1분 읽기
FDA Approves Labeling for Discontinued Enalapril/Hydrochlorothiazide ANDA076486
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.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Camber Pharmaceuticals Gets FDA ANDA Approval for Olmesartan/Amlodipine/HCTZ Tablet
The FDA approved ANDA209242 for Camber’s prescription oral tablet combining olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in multiple strengths.
UPDATED
규제 업데이트
2026년 9월 22일•1분 읽기
FDA Approves Irbesartan/Hydrochlorothiazide Combination Tablets (ANDA 077446)
The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Lupin Losartan Potassium/Hydrochlorothiazide Combination (ANDA078245)
FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.
UPDATED
규제 업데이트
2026년 9월 16일•1분 읽기
FDA Records Submissions for Teva’s Discontinued Amlodipine/Valsartan/HCTZ Tablets (ANDA 200435)
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.
UPDATED
규제 업데이트
2026년 9월 10일•1분 읽기
FDA Approves ANI PHARMS' Fosinopril/HCTZ Tablets (ANDA 076608)
The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
Quinapril Hydrochloride and Hydrochlorothiazide Tablets – FDA Labeling Approvals (ANDA 077093)
FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.
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규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves Teva Hydrochlorothiazide 50 mg Tablet (ANDA 088923)
The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ANDA081189 for Hydrochlorothiazide 25 mg Tablet by Watson Labs
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.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ANDA 085208 for Hydrochlorothiazide 50 mg Oral Tablet (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.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
SUN PHARM INDS LTD Benazepril/Hydrochlorothiazide ANDA (ANDA077483) Products Discontinued
FDA records show four oral tablet products of benazepril hydrochloride and hydrochlorothiazide under ANDA077483 are discontinued, with multiple supplemental labeling approvals.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ANDA083666 for Hydrochlorothiazide/Reserpine Oral Tablet
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.