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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

#Sandoz ×

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규제 업데이트
2026년 9월 25일•1분 읽기
FDA Approves Manufacturing Supplements for Sandoz Orphenadrine Citrate ER Tablet (ANDA 085046)
The FDA has approved several manufacturing (CMC) supplement submissions for Sandoz’s Orphenadrine Citrate extended‑release tablet (ANDA 085046), which is currently listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 25일•1분 읽기
FDA Approves ANDA090137 for Sandoz Irinotecan Hydrochloride Injection
FDA approved Sandoz's ANDA090137 covering two Irinotecan Hydrochloride injectable products, both listed with discontinued marketing status.
UPDATED
규제 업데이트
2026년 9월 25일•1분 읽기
Sandoz Secures Tentative FDA Approval for Generic Rosiglitazone Maleate Tablets (ANDA078674)
Sandoz's ANDA078674 for oral rosiglitazone maleate tablets (2 mg, 4 mg, 8 mg) has received tentative approval from the FDA as of March 9 2009.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
FDA Approves Sandoz Generic Trifluoperazine Hydrochloride Tablet (ANDA085785)
The FDA has approved ANDA085785 for Sandoz’s oral tablet of trifluoperazine hydrochloride, a prescription drug, with multiple manufacturing and labeling approvals spanning 1982‑1999.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Sandoz ALPHAZINE (phendimetrazine) ANDA085034
The FDA approved ANDA085034 for ALPHAZINE, a 35 mg phendimetrazine tartrate oral tablet by Sandoz, with original and supplemental approvals spanning 1978‑1991.
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 15일•1분 읽기
Sandoz Receives FDA Tentative Approval for Epinastine Hydrochloride Ophthalmic Solution (ANDA090950)
Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.
UPDATED
규제 업데이트
2026년 9월 15일•1분 읽기
FDA Approves Sandoz Children’s Cetirizine Hydrochloride Chewable Tablets (ANDA 078692)
The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.
UPDATED
규제 업데이트
2026년 9월 9일•1분 읽기
FDA Approves Sandoz Ondansetron Hydrochloride Preservative‑Free Injection (ANDA 077551)
Sandoz received FDA approval for a generic ondansetron hydrochloride injection (preservative‑free) under ANDA 077551, with original and supplemental labeling approvals dating from 2007 to 2015.
UPDATED
규제 업데이트
2026년 9월 8일•1분 읽기
FDA Approves Sandoz ANDA076873 for Metformin Hydrochloride Extended‑Release Tablet
The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
FDA Approves Sandoz DRALSERP Tablet (Hydralazine HCl/Reserpine) – ANDA084617
The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 5일•1분 읽기
FDA Approves ANDA085964 for Acetaminophen and Codeine Phosphate Tablet
The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.