Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Trimethobenzamide Injection (ANDA 089094)
The FDA has listed the injectable Trimethobenzamide Hydrochloride (product 001) from sponsor SoloPak as discontinued under ANDA 089094.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA077826 for Fenoldopam Mesylate Injection
The FDA has approved an Abbreviated New Drug Application (ANDA077826) for fenoldopam mesylate injection submitted by Teva Parenteral.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Hikma’s Indomethacin Sodium Injection (ANDA 078713)
The FDA has approved ANDA 078713 for Hikma’s injectable Indomethacin Sodium, though the product is listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA Approval for Voriconazole Injection (ANDA220043)
The FDA approved an ANDA for Voriconazole injection, a 10 mg/mL intravenous antifungal solution, sponsored by Hainan Poly Pharm.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Zydus Verapamil Hydrochloride Injection (ANDA214215)
FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)
The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.
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 Approves HIKMA ANDA062720 for Cephapirin Sodium Injection (Discontinued Products)
The FDA approved HIKMA's ANDA062720 for cephapirin sodium injectable products, all listed as discontinued, with approval dated July 2, 1987.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA203048 for Clindamycin Phosphate Injection by Rising
The FDA granted approval for Rising’s clindamycin phosphate injection products (6, 12, and 18 mg/mL) under application ANDA203048.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA201251 for Vancomycin Hydrochloride Injection
FDA approved ANDA201251 submitted by Teva Pharm USA for two vancomycin hydrochloride injectable products (500 mg and 1 g per vial), both listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 089107)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor PharmaFair as discontinued under ANDA 089107.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Multiple Potassium Chloride Injection Products (ANDA080195)
The FDA’s ANDA080195 filing shows that MILES’ injectable potassium chloride products (1–4 mEq/mL) are listed as discontinued.