Regulatory Updates

FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.

The FDA has approved ANDA 084279 for a prescription oral tablet combining 500 mg probenecid and 0.5 mg colchicine, marketed by Actavis Pharma.

TABLICAPS has filed ANDA085207 for an oral 0.25 mg Reserpine tablet, which is listed with a discontinued marketing status.

Watson Labs' oral tablet GUANETHIDINE MONOSULFATE (product 001) is listed as discontinued in FDA records under ANDA 086114.

The FDA granted approval (ANDA084351) for a 4 mg oral tablet of brompheniramine maleate by IVAX Sub Teva Pharm; the product is currently listed as discontinued.

FDA approved KV PHARM's oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate (ANDA085288). Multiple labeling submissions were filed; the product is now discontinued.

The FDA has approved a series of labeling and REMS submissions for the prescription oral tablet combining 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen under ANDA 076604.

FDA has approved ANDA076885 for Rabeprazole Sodium oral delayed‑release tablets (20 mg) sponsored by Pharmobedient, with multiple labeling submissions approved between 2013 and 2023.

FDA has approved ANDA083666 submitted by Watson Labs for an oral tablet combining 50 mg hydrochlorothiazide and 0.125 mg reserpine; the product is listed as discontinued.

The FDA approved ANDA 084744 on Dec 9 1975 for Meprobamate tablets (200 mg and 400 mg) marketed by Parke Davis, now listed as discontinued.

FDA approved multiple labeling submissions for Teva's granisetron hydrochloride oral tablet (ANDA078080), which is listed as discontinued.

The FDA approved labeling submissions for the oral tablet containing norethindrone 0.4 mg and ethinyl estradiol 0.035 mg (ANDA078379) submitted by Watson Labs.