Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA077076 for Lorazepam Injectable Products
FDA approved ANDA077076 submitted by Bedford for Lorazepam injectable products (2 mg/mL and 4 mg/mL), both listed as discontinued.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA 076233 for Paclitaxel Injection (Hospira)
The FDA granted approval for ANDA 076233, a Paclitaxel injectable (6 mg/mL) submitted by Hospira. Original approval 2002, labeling supplement 2007.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA077947 for Fluconazole Injectable Products (Discontinued)
The FDA has approved ANDA077947 submitted by Baxter Healthcare Corp for two discontinued Fluconazole injectable products in 0.9% sodium chloride, strengths 200 mg/100 mL and 400 mg/200 mL.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Lorazepam Injectable (ATIVAN) NDA018140
The FDA granted approval for NDA018140, authorizing Lorazepam injectable (brand name ATIVAN) from Hikma Pharmaceuticals USA and Civica, Inc.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues Testosterone Enanthate Injectable Products (ANDA083667)
The FDA has discontinued two injectable testosterone enanthate products from Watson Labs, listed under ANDA083667.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues FOLEX Injectable Methotrexate Products (ANDA087695)
The FDA's ANDA087695 filing for FOLEX injectable methotrexate (25 mg, 50 mg, 100 mg) shows all three products are listed as discontinued.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA078145 for Ketorolac Tromethamine Injectable Products
The FDA has approved ANDA078145 for two injectable ketorolac tromethamine products (15 mg/mL and 30 mg/mL), both listed as discontinued.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Lidocaine Hydrochloride Injection (NDA 017584)
The FDA has approved preservative‑free lidocaine hydrochloride injectable products (2% and 4%) under NDA 017584, manufactured by Fresenius Kabi USA.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 077139 for Teva’s Intravenous Carboplatin Injectable Products
The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Testosterone Injectable (Product 001) – Submission History
The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.