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FDA Approval Activities for this Drug…
AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Abbott 075761 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL AM PHARM PARTNERS 076394 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Apotex 076018 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Bedford 076299 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Bedford LABS 076088 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Ben Venue 076217 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Bioniche (CANADA) 021594 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HYDROCHLORIDE INTL MEDICATION SYS 076108 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Mayne PHARMA USA 076163 AP No AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML AMIODARONE HCL Sicor PHARMS 020377 AP Yes AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION 50MG/ML CORDARONE Wyeth PHARMS INC 075188 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG AMIODARONE HCL Alphapharm 075389 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG AMIODARONE HCL Barr 074739 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG AMIODARONE HCL Copley PHARM 075315 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG AMIODARONE HCL Eon 075315 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 400MG AMIODARONE HCL Eon 075424 No AMIODARONE HYDROCHLORIDE TABLET; ORAL 100MG AMIODARONE HCL Taro 075424 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG AMIODARONE HCL Taro 076362 No AMIODARONE HYDROCHLORIDE TABLET; ORAL 300MG AMIODARONE HCL Taro 076362 AB Yes AMIODARONE HYDROCHLORIDE TABLET; ORAL 400MG AMIODARONE HCL Taro 074895 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG AMIODARONE HCL Teva 075135 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG PACERONE Upsher Smith 018972 AB No AMIODARONE HYDROCHLORIDE TABLET; ORAL 200MG CORDARONE Wyeth PHARMS INC Amiodarone Hydrochloride Apotex . 76-394 4/25/03 Amiodarone Hydrochloride Bedford 76-299 10/24/02 Amiodarone Hydrochloride Bioniche Pharma Ltd. 76-217 10/15/02 Amiodarone Hydrochloride Bioniche Pharma Ltd. 76-217 7/10/02 Amiodarone Hydrochloride Sicor 76-163 9/5/03 Amiodarone Hydrochloride Faulding Pharmaceutical Co. 76-108 10/15/02 Amiodarone Hydrochloride Faulding Pharmaceutical Co. 76-108 4/12/02 Amiodarone Hydrochloride Ben Venue, 76-088 10/15/02 Amiodarone Hydrochloride Ben Venue, 76-088 7/17/02 Amiodarone Hydrochloride Bedford 76-018 10/15/02 Amiodarone Hydrochloride Bedford 76-018 5/7/02 Amiodarone Hydrochloride Abbott 75-955 10/18/02 Amiodarone Hydrochloride American Pharmaceutical Partners, 75-761 10/15/02 Amiodarone Hydrochloride American Pharmaceutical Partners, 75-761 8/23/01 4/15/03 Amiodarone Hydrochloride Taro Pharmaceutical Industries Ltd. 76-362 11/29/02 Amiodarone Hydrochloride Taro Pharmaceutical Industries Ltd. 75-424/S1 12/18/02 Amiodarone Hydrochloride Taro Pharmaceutical Industries Ltd. 75-424 3/30/01 3/30/01 Amiodarone Hydrochloride Barr, 75-389 1/25/01 3/5/01 Amiodarone Hydrochloride Eon Labs Manufacturing, 75-315 12/23/98 12/23/98 8/6/03 Amiodarone Hydrochloride Alphapharm Pty/Par 75-188 2/24/99 12/31/01 12/31/01 12/31/01 Amiodarone Hydrochloride Usher-Smith , 75-315/S005/6/7 4/12/00 10/29/02 Amiodarone Hydrochloride Eon Labs Manufacturing, 75-315/S004/5 6/30/00 10/30/00 Amiodarone Hydrochloride Upsher-Smith , 75-135/S4 2/1/00 10/29/02 Amiodarone Hydrochloride Upsher-Smith , 75-135/S1 12/2/99 10/29/02 Amiodarone Hydrochloride Upsher-Smith , 75-135/S2 12/2/99 10/29/02 Amiodarone Hydrochloride Copley Pharmaceutical 74-739 11/30/98 12/4/98 1/15/02 1/15/02 Amiodarone Hydrochloride Novopharm Limited 74-895 Cordarone (Amiodarone HCl) Intravenous, Wyeth 20-377/S14 5/6/03 7/9/03 Cordarone (Amiodarone HCl) Intravenous, Wyeth 20-377/S13 5/6/03 7/9/03 Cordarone (Amiodarone HCl) Intravenous, Wyeth 20-377/S10 & S12 5/9/03 7/9/03 Cordarone (Amiodarone HCl) Intravenous Wyeth 20-377/S4 & S5 7/11/01 2/14/02 Cordarone (Amiodarone HCl) Wyeth 18-972/S-026 5/6/03 7/9/03 Cordarone (Amiodarone HCl) Wyeth 18-972/S-025 12/18/02 1/29/03 Cordarone (Amiodarone HCl) Wyeth 18-972/S-023 4/30/03 Cordarone (Amiodarone HCl) Wyeth 18-972/S-019 & 18-972/S-020 10/8/99 7/05/01 Cordarone (Amiodarone HCl) Wyeth 18-972/S-015, S-017 1/5/99 6/25/99 Cordarone (Amiodarone HCl) Wyeth-Ayerst 18-972/S-014, S016 & S018 Pacerone (Amiodarone Hydrochloride) Upsher-Smith , 75-135/S3 9/24/99 10/29/02 Pacerone (Amiodarone Hydrochloride) Upsher-Smith , 75-135/S1-7 4/30/98 10/29/02 Pacerone (Amiodarone Hydrochloride) Upsher-Smith , 75-135 Amiodarone Hydrochloride Taro Pharmaceutical Cordarone (amiodarone HCl) Tablets, Wyeth Pharmaceuticals Cordarone (amiodarone HCl) Intravenous, Wyeth Pharmaceuticals, Labeling Revision Cordarone (amiodarone HCl) Tablets, Wyeth Pharmaceuticals, Labeling Revision | Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision | Cordarone (amiodarone HCl) Intravenous, Wyeth Pharma, Labeling Revision | Cordarone (amiodarone HCl) Intravenous, Wyeth Pharma, Labeling Revision | Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision | Amiodarone Hydrochloride Tablets, Aurosal Pharma, Approval | Amiodarone Hydrochloride Injection, Apotex Corp., Approval | Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision | Cordarone (amiodarone HCl) Intravenous, Wyeth Pharma, Labeling Revision | Amiodarone Hydrochloride Injection, Akron, Inc., Approval | Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision
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