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

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