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FDA Approval Activities for this Drug…
COPEGUS (ribavirin) Tablets, 200 mg Hoffmann-La Roche NDA 21-511 Rebetol (ribavirin) Capsules, Schering NDA 20-903/S32 10/10/03 10/16/03 10/16/03 Rebetol (ribavirin) Capsules, Schering NDA 20-903/S028 6/9/03 7/8/03 7/8/03 Rebetol (ribavirin) Capsules, Schering NDA 20-903/S025 11/13/02 7/31/03 Rebetol (ribavirin) Capsules, Schering NDA 20-903/S023 9/3/02 9/5/02 Rebetol (ribavirin) Capsules, Schering NDA 20-903/S020 3/6/02 3/12/02 Rebetol (ribavirin) Capsules Schering NDA 20-903/S013 12/28/01 2/12/01 Rebetol (ribavirin) Solution, Schering NDA 21-546 7/29/03 8/6/03 8/6/03 Rebetol Rebetron Combination Therapy, Schering NDA 20-903/S030 7/9/03 7/10/03 7/9/03 Rebetol (ribavirin)/Intron A (interferon alfa-2b) (Rebetron Combination Therapy Schering NDA 20-903/S015 2/21/02 2/21/02 Rebetol (ribavirin)/Intron A (interferon alfa-2b) (Rebetron Combination Therapy Schering NDA 20-903/S008, S011, S012 & S016 7/25/01 7/26/01 7/26/01 Rebetol (ribavirin)/Intron A (interferon alfa-2b, recombinant) Schering NDA 20-903 6/3/98 6/3/98 6/3/98 9/7/01 Rebetol Indication:Treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha interferon therapy. Rebetron Combination Therapy, Schering-Plough NDA 20-903/ S-025 11/13/02 11/18/02 Rebetron Combination Therapy (Rx only)consisting of Rebetol (ribavirin)200mg capsules and Intron A (interferon Alfa-2b, recombinant)3 million IU injectable Schering-Plough NDA 20-903/ S-001/S-002 12/9/98 12/14/98 12/9/98 Rebetron Combination Therapy [SCH 30500 - Intron A (Interferon alfa-2b, recombinant) for Injection/ SCH 18908 - Ribavirin]., Schering-Plough NDA 20-903/S-006 & S-007 RIBAVIRIN Capsule; 200MG REBETOL SCHERING PLOUGH RES 020903 RIBAVIRIN Capsule; 200MG ***SEE 23RD ANNUAL OB SECTION 1.8 DESCRIPTION OF SPECIAL SITUATIONS: RIBAVIRIN ORAL 200MG CAPSULE*** REBETOL SCHERING PLOUGH RES 018859 RIBAVIRIN For Solution; Inhalation 6GM/VIAL VIRAZOLE ICN 021546 RIBAVIRIN Solution; 40MG/ML REBETOL SCHERING 021511 RIBAVIRIN Tablet; 200MG COPEGUS ROCHE Ribasphere (Ribavirin) Capsules, Three River Pharmaceuticals Ribavirin Capsules, Sandoz, Inc. Copegus (RIBAVIRIN), Hoffman-La Roche Inc. Rebetron Combination Therapy, Schering Corporation Rebetol and Rebetron Combination Therapy, Schering Corporation | Ribavirin Capsule, Teva Pharma, Tentative Approval | Ribavirin Capsules, Teva Pharma, Approval | Copegus (ribavirin) tablets, Hoffmann-La Roche, New or Modified Indication | COPEGUS (ribavirin, USP) Tablets, Hoffmann-La Roche, Formulation Revision | Copegus (ribavirin) in combo w/Pegasys (peginterferon alfa-2a), Hoffman-La Roche, Labeling Revision | Copegus (ribavirin) in combo w/Pegasys (peginterferon alfa-2a), Hoffman-La Roche, Labeling Revision | Ribavirin Tablets, Teva Pharma, Approval | Ribavirin Tablets, Three Rivers Pharma, Tentative Approval | Ribavirin Capsules, Zydus Pharma, Approval | Copegus (ribavirin) Tablets, Hoffman-La Roche, Labeling Revision | Ribvirin Tablets, Teva Pharma, Approval | Ribvirin Tablets, Three Rivers Pharma, Approval | Ribvirin Tablets, Zydus Pharma, Approval | Rebetol Capsule, Schering Plough, Labeling Revision | Ribavirin Tablets, Sandoz, Inc., Approval | Ribavirin Tablets, Zydus Pharma, New Strength | Rebetol (ribavirin) Capsules and Oral solution, Schering Corp., Labeling Revision | Copegus (ribavirin) Tablets, Hoffmann-La Roche, Labeling Revision | REBETOL (ribavirin) Capsules and Oral Solution, Schering Corp., Labeling Revision | Ribavirin Tablets, Zydus Pharma, Packaging Addition | Ribavirin Tablets, Sandoz Inc., Control Supplement | COPEGUS (ribavirin) Tablets, Roche, Labeling Revision | Ribavirin Tablets, Three Rivers Pharmaceuticals, LLC, Packager Addition
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