Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Multiple Risperidone Tablet Strengths Under ANDA 078871
FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA076786 for Donepezil Hydrochloride Tablets – Marketing Status Discontinued
SUN PHARM INDS LTD's ANDA076786 for oral Donepezil Hydrochloride tablets (5 mg and 10 mg) has been approved by the FDA, with both products listed as discontinued.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA 077973 for Bicalutamide 50 mg Tablet – Synthon Pharm
FDA approves ANDA 077973 for Synthon Pharm’s 50 mg oral bicalutamide tablet; labeling approved in 2009 and manufacturing in 2011.
Regulatory Updates
Sep 25, 2026•1 min read
FDA ANDA077657: Lorazepam Tablet Discontinuations and Submission History
The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.
Regulatory Updates
Sep 25, 2026•1 min read
Bell Pharma’s Chlorpheniramine Maleate Tablet (ANDA083062) Listed as Discontinued
Bell Pharma’s oral tablet of chlorpheniramine maleate (4 mg) under ANDA083062 has been marked as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 077780 for Carvedilol Tablets by TARO
FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.
1
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Multiple Supplemental Applications for Discontinued Chlorothiazide Tablets (ANDA 084217)
The FDA record for ANDA 084217 lists two discontinued oral chlorothiazide tablets (500 mg and 250 mg) and a series of approved supplemental submissions covering manufacturing, labeling and bioequivalence.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Manufacturing Submission for Mylan’s Thioridazine Hydrochloride Tablet (ANDA088332)
The FDA has approved Mylan’s supplemental application (ANDA088332) for a 10 mg oral tablet of thioridazine hydrochloride, though the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
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.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Discontinued Chlorpromazine Tablets
FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Issues ANDA084080 for Promethazine Hydrochloride Tablet
FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Lists Prednisolone 5 mg Tablet (ANDA080236) from Valeant as Discontinued
The FDA database shows a prednisolone 5 mg oral tablet submitted under ANDA080236 by Valeant Pharmaceuticals International, currently marked as discontinued.