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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Multiple Supplemental Submissions for Phentermine Hydrochloride (ANDA 088596)
The FDA has approved a series of supplemental labeling and manufacturing submissions for the discontinued oral tablet Phentermine Hydrochloride (37.5 mg) under ANDA 088596.
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규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves ANDA077672 for Stavudine Capsules by Aurobindo Pharma
FDA has approved labeling submissions for ANDA077672 covering stavudine oral capsules from Aurobindo Pharma; all listed products are marked discontinued.
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규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Over-the-Counter Famotidine ANDA077367 for Dr. Reddy's Labs
The FDA has granted approval for an over‑the‑counter famotidine tablet (10 mg and 20 mg) under ANDA 077367, sponsored by Dr. Reddy’s Laboratories Ltd.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
2023 Korean Pediatric Inpatient Self‑Sufficiency Below Avg in 63% of Regions
Analysis of NHIS data shows that in 2023, 38 of 60 Korean medical districts (63.3%) had pediatric inpatient self‑sufficiency rates below the national average of 79%.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves ANDA077968 for Alprazolam Extended‑Release Tablets (IMPAX Labs)
The FDA approved ANDA077968 on May 24, 2007 for IMPAX Labs' oral extended‑release alprazolam tablets, all listed as discontinued products.
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규제 업데이트
2026년 9월 19일•1분 읽기
FDA Discontinues UTICORT Topical Lotion (NDA017528)
The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.
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규제 업데이트
2026년 9월 19일•1분 읽기
FDA NDA006920: Lederle's Triple Sulfas Oral Products Listed as Discontinued
The FDA’s NDA006920 for Lederle’s oral drug Triple Sulfas includes two discontinued formulations—a suspension and a tablet—both containing trisulfapyrimidines, sulfamerazine, and sulfamethazine.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Lists Fexofenadine Hydrochloride Products Under ANDA076502
The FDA database shows multiple oral tablet products of Fexofenadine Hydrochloride under application ANDA076502, with strengths from 30 mg to 180 mg, some discontinued and others OTC.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Sandoz OFLOXACIN Ophthalmic Solution (ANDA 076231)
The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Gemcitabine Injection (ANDA079183)
The FDA has approved the ANDA for gemcitabine injection (ANDA079183) from Hospira, Inc., with details on submission history and labeling updates.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Apotex Generic Tizanidine Hydrochloride Capsules (ANDA078868)
The FDA has approved Apotex’s generic Tizanidine Hydrochloride oral capsules (2 mg, 4 mg, 6 mg) under application ANDA078868.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Labeling Updates for Granisetron Injection (ANDA078564)
FDA has approved labeling supplements for ANDA078564, a discontinued Granisetron Hydrochloride injection product by Wockhardt USA, with submissions dated 2008, 2014, and 2015.