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FDA Approval Activities for this Drug… Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S48 & S52 8/27/03 8/29/03 8/29/03 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-051 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. (Patient Information) Hoffmann-La Roche NDA 18-662/S-047 4/12/02 4/16/02 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-046 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-044 10/30/01 11/2/01 11/2/01 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-043 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-041/045 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-040 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-039 Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. Hoffmann-La Roche NDA 18-662/S-038 Amnesteem (Isotretinoin) Capsules USP, 10, 20 & 40 mg, Genpharm ANDA 75-945 Claravis (Isotretinoin) Capsules, 10 mg, Barr ANDA 76-356 4/11/03 Claravis (Isotretinoin) Capsules, 20 & 40 mg, Barr ANDA 76-135 Sotret (Isotretinoin) Capsules, USP, 10, 20 & 40 mg, Ranbaxy Ltd. ANDA 76-041 ISOTRETINOIN Capsule; 10MG CLARAVIS Barr 076135 ISOTRETINOIN Capsule; 20MG CLARAVIS Barr 076135 ISOTRETINOIN Capsule; 40MG CLARAVIS Barr 075945 ISOTRETINOIN Capsule; 10MG AMNESTEEM Genpharm 075945 ISOTRETINOIN Capsule; 20MG AMNESTEEM Genpharm 075945 ISOTRETINOIN Capsule; 40MG AMNESTEEM Genpharm 018662 ISOTRETINOIN Capsule; 10MG ACCUTANE HLR 018662 ISOTRETINOIN Capsule; 20MG ACCUTANE HLR 018662 ISOTRETINOIN Capsule; 40MG ACCUTANE HLR 076041 ISOTRETINOIN Capsule; 10MG ISOTRETINOIN Ranbaxy 076041 ISOTRETINOIN Capsule; 20MG ISOTRETINOIN Ranbaxy 076503 ISOTRETINOIN Capsule; 30MG SOTRET Ranbaxy 076041 ISOTRETINOIN Capsule; 40MG ISOTRETINOIN Ranbaxy Accutane (isotretinoin) Capsules, Hoffman-La Roche, Labeling Revision | Claravis Capsules, Barr Labs, Approval Visit Betterchem's Drug Index for FDA's latest approval information.   Find other drugs… 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 | USActives.com | Pharma Job Search | Pharma Company News © 2011 FindingHealthOnline™