Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Digoxin Injection USP, 0.25 mg/mL, Sabex 2002, ANDA 40-481 8/21/03 Digoxin Injection USP, 0.25 mg/mL, 2mL ampul, Abbott ANDA 40-206 8/28/98 9/2/98 Digoxin Tablets USP, 0.125 mg and 0.25 mg., Caraco Pharmaceutical ANDA 76-393 1/31/03 Digoxin Tablets USP, 0.125 mg and 0.25 mg., Jerome Stevens ANDA 76-268 7/26/02 Digoxin Tablets USP, 0.125 mg and 0.25 mg. Amide Pharmaceutical, ANDA 40-282 Lanoxin (digoxin) Injection, 0.25 mg/mL, GlaxoSmithKline NDA 9-330/S-021 6/17/02 6/18/02 Lanoxin (Digoxin) Injection & Pediatric Injection & Lanoxicaps (Digoxin In Solution) Capsules Glaxo Wellcome, NDA 9-330/S020 & 18-118/S016 DIGOXIN Capsule; 0.05MG LANOXICAPS SMITHKLINE BEECHAM 018118 DIGOXIN Capsule; 0.1MG LANOXICAPS SMITHKLINE BEECHAM 018118 DIGOXIN Capsule; 0.2MG LANOXICAPS SMITHKLINE BEECHAM 040092 DIGOXIN Injection 0.1MG/ML DIGOXIN PEDIATRIC Abbott 040093 DIGOXIN Injection 0.25MG/ML DIGOXIN Abbott 040206 DIGOXIN Injection 0.25MG/ML DIGOXIN Abbott 083391 DIGOXIN Injection 0.25MG/ML DIGOXIN ELKINS SINN 009330 DIGOXIN Injection 0.1MG/ML LANOXIN PEDIATRIC GLAXOSMITHKLINE 009330 DIGOXIN Injection 0.25MG/ML LANOXIN GLAXOSMITHKLINE 040481 DIGOXIN Injection 0.25MG/ML DIGOXIN Sabex 2002 040282 DIGOXIN Tablet; 0.125MG DIGOXIN Amide 040282 DIGOXIN Tablet; 0.25MG DIGOXIN Amide 076363 DIGOXIN Tablet; 0.125MG DIGOXIN Caraco 076363 DIGOXIN Tablet; 0.25MG DIGOXIN Caraco 020405 DIGOXIN Tablet; 0.125MG LANOXIN SMITHKLINE BEECHAM 020405 DIGOXIN Tablet; 0.25MG LANOXIN SMITHKLINE BEECHAM 076268 DIGOXIN Tablet; 0.125MG DIGOXIN STEVENS J 076268 DIGOXIN Tablet; 0.25MG DIGOXIN STEVENS J Digoxin Elixir, Roxane Laboratories, Approval | Digoxin Tablets, Jerome Stevens Pharma, Control Supp. | Digoxin Tablets, Caraco Pharma, Control Supplement | Digoxin Tablets, West-ward Pharma, Approval ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com