The U.S. Food and Drug Administration has approved application ANDA211272 submitted by Teva Pharm USA for Mycophenolate Mofetil oral suspension.
The product is an oral suspension (FOR SUSPENSION) with a strength of 200 mg/mL. It is listed as discontinued and is not designated as a reference drug.
Submission history includes an original (ORIG) submission (submission number 1) approved on 2022-01-25, accompanied by a REMS document dated 2023-11-07. Subsequent supplementary submissions were also approved: submission 2 (Labeling) on 2024-10-17, submission 3 (REMS) on 2024-08-13, and submission 4 (REMS) on 2026-07-29.
The sponsor for this application is Teva Pharm USA.
法规动态2026年9月18日•3 分钟阅读
FDA Approves ANDA211272 for Mycophenolate Mofetil Oral Suspension
Teva Pharm USA's ANDA211272 for Mycophenolate Mofetil oral suspension (200 mg/mL) received FDA approval, with several REMS and labeling supplements also approved.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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