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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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UPDATED
규제 업데이트
2026년 9월 8일•1분 읽기
CENCI Announces Discontinuation of PROMETHAZINE Oral Syrup (ANDA089013)
CENCI's PROMETHAZINE oral syrup (product 001) is listed as discontinued in the FDA ANDA089013 filing.
UPDATED
규제 업데이트
2026년 9월 8일•1분 읽기
FDA Approves Labeling for Teva’s Discontinued Ramipril Capsules (ANDA 077470)
Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.
UPDATED
규제 업데이트
2026년 9월 8일•1분 읽기
FDA Approves ANDA083022 for DODEX Injectable (Cyanocobalamin)
The FDA approved ANDA083022 for the DODEX injectable containing 1 mg/mL cyanocobalamin. The product is listed as discontinued.
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UPDATED
규제 업데이트
2026년 9월 8일•1분 읽기
FDA Discontinues Isoniazid Oral Tablet (ANDA083632)
The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.
UPDATED
규제 업데이트
2026년 9월 8일•1분 읽기
FDA Discontinues ANDA 080086 for Triple Sulfa Oral Tablet by Purepac Pharm
The FDA has listed the ANDA 080086 submission for the oral tablet Triple Sulfa, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, as discontinued.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
FDA Approves ANDA080517 for Prednisolone Sodium Phosphate Injection
FDA approved an ANDA (ANDA080517) for Watson Labs' Prednisolone Sodium Phosphate injectable, originally submitted in 1974; the product is now listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA087592)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
FDA Discontinues FLUONID Topical Ointment (ANDA 087157)
The FDA lists the FLUONID ointment (0.025% fluocinonide) under ANDA 087157 as discontinued, sponsored by Allergan Herbert.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
FDA Lists Dextroamphetamine Sulfate Tablet (5 mg) as Discontinued – ANDA 086521
The FDA has marked the oral tablet product Dextroamphetamine Sulfate (5 mg) from sponsor MAST MM as discontinued under ANDA 086521.
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.
UPDATED
규제 업데이트
2026년 9월 4일•1분 읽기
King Pharm Discontinues Quinidine Sulfate Oral Tablet (ANDA 085175)
King Pharm's ANDA 085175 for quinidine sulfate 200 mg oral tablets is listed as discontinued by the FDA.
UPDATED
규제 업데이트
2026년 9월 4일•1분 읽기
FDA Approves ANDA090249 for Chloroquine Phosphate Tablet (IPCA Labs) – Now Discontinued
The FDA approved IPCA Labs' ANDA090249 for a 500 mg oral chloroquine phosphate tablet in 2009; the product is currently listed as discontinued.