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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA091667 for MISOPROSTOL Oral Tablets (Discontinued)
The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
Chartwell Rx Receives FDA Approval for TRAVOPROST Ophthalmic Solution (ANDA091340)
The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA083784 for Meclizine Hydrochloride 12.5 mg Tablet
The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA 080784 for PurePac Pharm Folic Acid Tablet
FDA has approved an ANDA for a 1 mg oral folic acid tablet submitted by PurePac Pharm; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
DIPHENHYDRAMINE HYDROCHLORIDE
FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA080279 for Prednisone 5mg Tablet by Inwood Labs
The FDA approved ANDA080279 for a 5 mg oral prednisone tablet submitted by Inwood Labs; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Grants ANDA079044 Approval for Nicotine Polacrilex Chewing Gum (OTC)
The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.
UPDATED
규제 업데이트
2026년 9월 24일•1분 읽기
FDA Approves ANDA078145 for Ketorolac Tromethamine Injectable Products
The FDA has approved ANDA078145 for two injectable ketorolac tromethamine products (15 mg/mL and 30 mg/mL), both listed as discontinued.
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UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
SOLVAY's TRANMEP Tablet (Meprobamate 400mg) Discontinued – ANDA084369
FDA records show SOLVAY's oral tablet TRANMEP, containing 400 mg meprobamate, is listed as discontinued under application ANDA084369.
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 23일•1분 읽기
Roche’s ENDEP (Amitriptyline HCl 150mg) ANDA085303 Approved; product now discontinued
The FDA approved Roche’s ANDA085303 for ENDEP, an oral 150 mg amitriptyline hydrochloride tablet. The product is currently listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
FDA Approves ANDA 084872 for Meclizine Hydrochloride 25 mg Tablet (BUNDY)
The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.