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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

#Meprobamate ×

UPDATED
규제 업데이트
2026년 9월 28일•1분 읽기
FDA Approves ANDA083919 for MILTOWN Oral Tablet (Meprobamate 600 mg)
The FDA has approved application ANDA083919 for MILTOWN, an oral tablet containing 600 mg of meprobamate, sponsored by Medpointe Pharm HLC.
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 19일•1분 읽기
FDA Approves ANDA083442 for Meprobamate 400mg Oral Tablet
The FDA approved ANDA083442 for a 400 mg oral tablet of meprobamate submitted by Whiteworth Town Plsn; the product is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 10일•1분 읽기
MEPROBAMATE (ANDA 085721) Discontinued Oral Tablet – FDA
FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.
UPDATED
규제 업데이트
2026년 8월 31일•1분 읽기
FDA Approves ANDA 084030 for Amosene 400 mg Meprobamate Tablet
The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.
UPDATED
규제 업데이트
2026년 8월 30일•1분 읽기
FDA Approves ANDA 084744 for Meprobamate Oral Tablets (200 mg & 400 mg)
The FDA approved ANDA 084744 on Dec 9 1975 for Meprobamate tablets (200 mg and 400 mg) marketed by Parke Davis, now listed as discontinued.
UPDATED
규제 업데이트
2026년 8월 25일•1분 읽기
FDA Approves ANDA080699 for Meprobamate Oral Tablets
The FDA granted approval for SUN PHARM INDUSTRIES' ANDA080699 covering oral Meprobamate tablets (200 mg and 400 mg). Multiple manufacturing and labeling submissions were approved between 1986 and 1998; the products are now discontinued.