Actualités réglementaires
27 sept. 2026•1 min de lecture
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.
Actualités réglementaires
19 sept. 2026•1 min de lecture
FDA Approves Gemcitabine Injection (ANDA079183)
The FDA has approved the ANDA for gemcitabine injection (ANDA079183) from Hospira, Inc., with details on submission history and labeling updates.
Actualités réglementaires
17 sept. 2026•1 min de lecture
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.
Actualités réglementaires
11 sept. 2026•1 min de lecture
FDA Approves ANDA206517 for Aztreonam Injectable Products
FDA has approved Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.
Actualités réglementaires
10 sept. 2026•1 min de lecture
FDA Grants Approval for Metoprolol Tartrate Injectable (ANDA078085) by Hospira
The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.
Actualités réglementaires
24 août 2026•1 min de lecture
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.