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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves ANDA076721 for Megestrol Acetate Oral Suspension
The FDA approved ANDA076721 for Megestrol Acetate oral suspension (40 mg/mL) submitted by PHARMOBEDIENT and manufactured by Xttrium Laboratories.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves Labeling for Fluticasone Propionate Nasal Spray (ANDA 078492)
The FDA has approved labeling for Chartwell RX's fluticasone propionate nasal spray (ANDA078492), a prescription nasal spray.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves ANDA084590 for Sodium Pentobarbital Oral Capsule (Discontinued)
The FDA has approved ANDA084590 for Sodium Pentobarbital 100 mg oral capsules by sponsor Anabolic; the product is listed as discontinued.
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UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves Multiple Submissions for Discontinued Hydrocodone/Acetaminophen Tablet
FDA records show approved manufacturing and labeling submissions for the discontinued oral tablet HYDROCODONE BITARTRATE AND ACETAMINOPHEN (500 mg/7.5 mg).
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Discontinues Nitrofurantoin Tablet (ANDA 084085) by Whiteworth Town PLsn
The FDA has listed the oral Nitrofurantoin 100 mg tablet (product 002) from Whiteworth Town PLsn as discontinued under ANDA 084085.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Lists ANDA080491 for Prednisone 5mg Oral Tablet by Elkins Sinn
The FDA database shows ANDA080491 for a 5 mg oral tablet of Prednisone submitted by Elkins Sinn, currently marked as discontinued.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves ANDA 087562 for Dipyridamole Oral Tablet (50 mg)
The FDA has approved ANDA 087562 submitted by IDT Australia Ltd for a 50 mg oral tablet of dipyridamole, originally listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA ANDA083453: Halsey Niacin 500 mg Tablet Listed as Discontinued
The FDA record (ANDA083453) shows Halsey’s oral Niacin 500 mg tablet (product 001) is marked discontinued and is not a reference drug.
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UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Discontinues PROCAN SR (ANDA086468) – Oral Extended-Release Tablet
FDA records indicate that PROCAN SR, an oral extended‑release tablet containing 250 mg procaineamide hydrochloride, has been discontinued. Sponsor Parke Davis filed multiple labeling submissions.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves ANDA079186 for Dorzolamide Hydrochloride Ophthalmic Solution
FDA granted approval for ANDA079186, a generic Dorzolamide Hydrochloride ophthalmic solution submitted by AM Regent, with original approval in 2009 and a labeling supplement in 2020.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves Multiple Risperidone Tablet Strengths Under ANDA 078871
FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.
UPDATED
규제 업데이트
2026년 9월 27일•1분 읽기
FDA Approves ANDA 078567 for Mylan’s Ciclopirox 8% Topical Solution
The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.