Regulatorische Updates

FDA approves ANDA 088184 for Hydroxyzine Hydrochloride injectable product by Fresenius Kabi USA, with multiple labeling and manufacturing submissions.

FDA approved Sandoz's ANDA090137 covering two Irinotecan Hydrochloride injectable products, both listed with discontinued marketing status.

The FDA record for NDA018025 shows the injectable form of furosemide marked as discontinued after a series of approved labeling and manufacturing supplemental submissions.

The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.

The FDA has approved ANDA 088371 for a cyclophosphamide injectable product (100 mg/vial) marketed by Baxter Healthcare, with multiple manufacturing and labeling submissions approved.

The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.

Pharmobedient received FDA approval (ANDA209932) for its magnesium sulfate 5% injection in a plastic container, designated as a prescription product.

FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.

FDA granted labeling approval for HIKMA Farmaceutica's ciprofloxacin 400 mg/200 mL injection under ANDA078431, with multiple supplemental approvals since 2009.

The FDA approved ANDA076296 for a Vincristine Sulfate injectable (1 mg/mL) submitted by Fresenius Kabi USA. The product is listed as discontinued.

The FDA has approved the ANDA for gemcitabine injection (ANDA079183) from Hospira, Inc., with details on submission history and labeling updates.

FDA has approved labeling supplements for ANDA078564, a discontinued Granisetron Hydrochloride injection product by Wockhardt USA, with submissions dated 2008, 2014, and 2015.