Regulatorische Updates

Teva submitted ANDA080921 for its oral capsule product Vitamin A Solubilized, containing vitamin A palmitate (EQ 50,000 units). The product is listed as discontinued.

The FDA has approved ANDA084590 for Sodium Pentobarbital 100 mg oral capsules by sponsor Anabolic; the product is listed as discontinued.

FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.

FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.

FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.

The FDA approved ANDA081069 for an oral capsule containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen, sponsored by Mikart. The product is listed as discontinued.

FDA has approved application ANDA210929 for tacrolimus oral capsules submitted by Hangzhou Zhongmei Huadong Pharmaceutical, with three discontinued dosage strengths listed.

The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.

FDA approved labeling for Jubilant Generics' oral itraconazole 100 mg capsule (ANDA203445); the product is listed as discontinued.

FDA has approved ANDA202711 for Zydus Pharms' prescription indomethacin 75 mg extended‑release oral capsule, with labeling supplements filed in 2017, 2019, 2021 and 2024.

FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.

FDA approved ANDA083457 for MK Labs' oral Vitamin A capsule products, both listed as discontinued, with details on dosage strengths and submission date.