Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Dextrose 10% & Sodium Chloride 0.9% Injectable (Now Discontinued)
The FDA record NDA018047 shows approval of an injectable solution containing 10% dextrose and 0.9% sodium chloride, now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing Submissions for Discontinued Trimpex Trimethoprim Tablets
The FDA’s NDA 017952 record lists two discontinued oral Trimpex tablets (100 mg and 200 mg trimethoprim) and documents a series of approved manufacturing and labeling submissions spanning 1980‑1997.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA063264 for Amikacin Sulfate Injection
The FDA approved ANDA063264 for Amikacin Sulfate injectable by Hospira. The product is listed as discontinued and includes multiple labeling and manufacturing supplemental submissions.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Registers Manufacturing Submissions for Discontinued Ibuprofen Tablet (ANDA 071144)
The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for Discontinued Ibuprofen Tablet
The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).
Regulatory Updates
Sep 16, 2026•1 min read
FDA Submissions for CALAN Verapamil Tablets (NDA 018817)
The FDA record for NDA 018817 lists multiple labeling and manufacturing submissions for CALAN verapamil tablets, all currently marked as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Multiple Submissions for Indomethacin NDA 018858, Products Discontinued
The FDA has approved a series of manufacturing and labeling submissions for Indomethacin (NDA 018858). Both listed capsule products (25 mg and 50 mg) are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Records Show Discontinued BENEMID (Probenecid) Tablet with Multiple Priority Submissions
The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for SLO‑BID (Theophylline 50 mg)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA087564 for Isosorbide Dinitrate Tablet
The FDA approved application ANDA087564 for Sun Pharm Industries' oral tablet Isosorbide Dinitrate 30 mg, listed with a discontinued marketing status.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Propoxyphene Compound-65 Oral Capsule
The FDA lists PROPOXYPHENE COMPOUND-65 oral capsules as discontinued, detailing its active ingredients and a series of manufacturing and labeling submissions from 1976 to 1995.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves INDIUM DTPA IN 111 (NDA 017707) for Intrathecal Diagnostic Use
The FDA has approved INDIUM DTPA IN 111 (NDA 017707), a radiopharmaceutical for intrathecal diagnostic imaging, manufactured by Medi‑Physics/GE Healthcare.
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