Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Accutane (isotretinoin) Capsules, Hoffman La-Roche, Labeling Revision | Accutane (isotretinoin) Capsules, Hoffman La-Roche, Inc., Labeling Revision | Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc., Labeling Revision | Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc., Labeling Revision | Absorica, isotretinoin, Capsule; Oral, Cipher Pharms Inc, Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com