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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
For the latest approval information, please locate this drug using this index. |
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