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# 20 Drug Determinations on ANDA Availability
- URL: https://www.fdaweb.com/20-drug-determinations-on-anda-availability/
- Published: 2021-01-08T12:00:00.000Z
- Updated: 2026-09-14T16:42:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148403

*Federal Register* notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Affected drugs are as follows:

NDA 006002 Sanofi-Aventis’ Aralen (chloroquine phosphate)

NDA 006134 Hikma Pharmaceuticals’ Dolophine Hydrochloride (methadone hydrochloride)

NDA 007409 Allergan Pharmaceuticals’ Bentyl (dicyclomine hydrochloride)

NDA 008085 Dava Pharmaceuticals’ methotrexate sodium

NDA 008678 Sandoz’ Isoniazid

NDA 012945 Teva’s Diamox (acetazolamide)

NDA 014103 Eli Lilly’s Oncovin (vincristine sulfate)

NDA 016792 Teva’s Surmontil (trimipramine maleate)

NDA 016801 Fresenius Kabi Xylocaine Pre-Servative Free (lidocaine hydrochloride)

NDA 018238 Nesher Pharmaceuticals’ Micro–K (potassium chloride)

NDA 019568 Valeant Pharmaceuticals’ Dermatop (prednicarbate)

NDA 020192 Novartis’ Lamisil (terbinafine hydrochloride)

NDA 020482 Bayer’s Precose (acarbose)

NDA 020591 AbbVie’s Tarka (trandolapril; verapamil hydrochloride)

NDA 020635 Janssen’s Levaquin (levofloxacin)

NDA 020823 Novartis’ Exelon (rivastigmine tartrate)

NDA 020920 Scios Natrecor (nesiritide)

NDA 021549 Merck’ Emend (aprepitant)

NDA 021590 Jazz Pharmaceuticals’ Fazaclo ODT (clozapine)

NDA 202535 Ferring Pharmaceuticals Prepopik (citric acid, magnesium oxide and sodium picosulfate)

To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-01-08/pdf/2021-00118.pdf?ref=fdaweb.com).