Regulatory Updates

FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.

Sandoz received FDA approval for a generic ondansetron hydrochloride injection (preservative‑free) under ANDA 077551, with original and supplemental labeling approvals dating from 2007 to 2015.

FDA records show Quad Pharms' Isoniazid injectable (100 mg/mL) under ANDA089816 is marked as discontinued.

FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.

The FDA approved ANDA083022 for the DODEX injectable containing 1 mg/mL cyanocobalamin. The product is listed as discontinued.

The FDA approved ANDA081142 for an aminophylline injectable product (25 mg/mL) submitted by Teva Parenteral, with original and supplemental approvals in 1991 and 1995.

FDA has approved NDA007392 for Seconal Sodium injectable, a secobarbital sodium product by Lilly, with a detailed submission history and discontinued marketing status.

FDA approved an ANDA (ANDA080517) for Watson Labs' Prednisolone Sodium Phosphate injectable, originally submitted in 1974; the product is now listed as discontinued.

The FDA received ANDA080667 from sponsor Luitpold for a thiamine hydrochloride injectable product, listed as discontinued.

FDA has approved application ANDA078052 for fosphenytoin sodium injection, a prescription product by Fresenius Kabi USA for IM and IV use.

FDA records show two Woodward Milrinone Lactate injectable products are listed as discontinued under ANDA077151.

FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.