Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA086148 for Amitriptyline Hydrochloride 150 mg Oral Tablet
The FDA has approved application ANDA086148 submitted by Roxane for a 150 mg oral tablet of amitriptyline hydrochloride, now listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA 084640 for DIPHEN Oral Elixir (USL Pharma)
FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Mellaril‑S Oral Suspension (NDA 017923)
The FDA has approved several manufacturing (CMC) and labeling submissions for the discontinued oral suspension Mellaril‑S, containing thioridazine, under NDA 017923.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Supplemental Manufacturing Submissions for Discontinued Sodium Chloride 0.45% Irrigation Solution
The FDA has approved a series of supplemental manufacturing (CMC) and labeling submissions for the discontinued irrigation product SODIUM CHLORIDE 0.45% in plastic containers.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Discontinues TOLECTIN Oral Tolmetin Products (NDA017628)
The FDA has marked the oral Tolmetin tablets TOLECTIN 600 mg and TOLECTIN 200 mg as discontinued, with a record of multiple manufacturing and labeling submissions from 1979 to 1993.
Regulatory Updates
Sep 11, 2026•1 min read
Oncogenic Therapeutics Secures US Patent for New Crystal Form and Manufacturing Method of Nesuparib
Oncogenic Therapeutics received a US patent decision for Nesuparib’s high‑purity crystal form and its manufacturing process, extending protection through May 2042 ahead of US clinical trials.
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Regulatory Updates
Sep 11, 2026•1 min read
FDA Approval History for CYLERT (NDA 017703)
CYLERT, an oral chewable tablet with 37.5 mg PEMOLINE, is listed as discontinued. The FDA record shows a series of labeling, manufacturing and priority submissions from 1976 to 2005.
Regulatory Updates
Sep 10, 2026•1 min read
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.
Regulatory Updates
Sep 10, 2026•1 min read
FDA ANDA084751 Approval for DILOR-400 (400 mg Theophylline)
DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions
The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.
Regulatory Updates
Sep 9, 2026•1 min read
CAM-METRAZINE (ANDA085320) Discontinued Oral Tablet by Chartwell Rx
Chartwell Rx’s oral tablet CAM-METRAZINE, containing 35 mg phendimetrazine tartrate, is listed as discontinued. The FDA ANDA record shows multiple manufacturing and labeling submissions.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Multiple Submissions for Lidocaine Hydrochloride Injection (Discontinued Product)
The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.
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