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.

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.

FDA Approves ANDA211272 for Mycophenolate Mofetil Oral Suspension

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