Actualités réglementaires

The FDA has listed the oral Nitrofurantoin 100 mg tablet (product 002) from Whiteworth Town PLsn as discontinued under ANDA 084085.

FDA records indicate that PROCAN SR, an oral extended‑release tablet containing 250 mg procaineamide hydrochloride, has been discontinued. Sponsor Parke Davis filed multiple labeling submissions.

The FDA has discontinued two injectable testosterone enanthate products from Watson Labs, listed under ANDA083667.

The FDA has listed the ANDA084700 application for Chlordiazepoxide Hydrochloride 10 mg oral capsules as discontinued. Sponsor Roxane filed the original ANDA in 1976.

The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.

The FDA records show that the injectable product Wellcovorin, containing Leucovorin Calcium (50 mg per vial), has been marked as discontinued under ANDA089465.

The FDA has listed the oral prednisolone 5 mg tablet (product 001) from sponsor Bundy as discontinued under ANDA083675.

The FDA records show PAMELOR oral solution (nortriptyline hydrochloride) is discontinued, with a history of labeling and manufacturing submissions from 1977 to 2014.

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