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… Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Purepac Pharmaceutical Co. ANDA 76-308 9/17/02 | Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Roxane, ANDA 76-270 1/14/03 | Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Amide ANDA 76-241 6/25/03 | Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Amide ANDA 76-241 2/12/03 | Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Alphapharm Pty Limited ANDA 76-176 2/25/02 | Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Mylan ANDA 76-122 1/15/02 4/10/03 | Mirtazapine Tablets, 15 & 30 mg, Teva ANDA 76-119 1/24/03 | Mirtazapine Tablets, 15 mg, 30 mg and 45 mg, Teva ANDA 76-119 Remeron (mirtazapine) Tablets, 15, 30 & 45 mg, Organon NDA 20-415/S15 9/30/02 10/2/02 | Remeron (mirtazapine) Tablets, 15, 30 & 45 mg, Organon NDA 20-415/S9 4/9/02 4/16/02 4/9/02 | Remeron Soltab (mirtazapine) Orally Disintegrating Tablets, 15 mg, 30 mg, and 45 mg, Organon NDA 21-208/S6 11/14/02 7/24/03 | Remeron Soltab (mirtazapine) Orally Disintegrating Tablets, 15 mg, 30 mg, and 45 mg, Organon NDA 21-208 1/12/01 4/29/02 4/29/02 4/29/02 | Remeron Indications: Depression. MIRTAZAPINE Tablet, Orally Disintegrating; 15MG REMERON SOLTAB ORGANON USA INC | 021208 MIRTAZAPINE Tablet, Orally Disintegrating; 30MG REMERON SOLTAB ORGANON USA INC | 021208 MIRTAZAPINE Tablet, Orally Disintegrating; 45MG REMERON SOLTAB ORGANON USA INC | 076176 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Alphapharm 076176 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Alphapharm 076176 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Alphapharm 076241 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Amide 076241 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Amide 076241 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Amide 076336 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Andrx 076336 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Andrx 076336 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Andrx 076219 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Eon 076219 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Eon 076219 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Eon 076189 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Geneva 076189 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Geneva 076189 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Geneva 076122 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Mylan | 076122 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Mylan | 076122 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Mylan | 020415 MIRTAZAPINE Tablet; 15MG REMERON ORGANON USA INC | 020415 MIRTAZAPINE Tablet; 30MG REMERON ORGANON USA INC | 020415 MIRTAZAPINE Tablet; 45MG REMERON ORGANON USA INC | 076308 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Purepac 076308 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Purepac 076308 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Purepac 076270 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Roxane | 076270 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Roxane | 076270 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Roxane | 076119 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Teva | 076119 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Teva | 076119 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Teva | 076312 MIRTAZAPINE Tablet; 15MG MIRTAZAPINE Watson 076312 MIRTAZAPINE Tablet; 30MG MIRTAZAPINE Watson 076312 MIRTAZAPINE Tablet; 45MG MIRTAZAPINE Watson Mirtazapine Tablets, Barr Laboratories Remeron (mirtazapine) Immediate-Release, Organon Inc. | Remeron SolTab (mirtazapine) Orally Disintegrating Tablets, Organon Inc. | Mirtazapine Tablets, Aurobindo Pharma, Approval | Remeron (mirtazapine) Immediate-Release Tablets, Organon Inc. , Labeling Revision | Remeron SolTab (mirtazapine) Orally Disintegrating Tablets, Organon Inc. , Labeling Revision | Mirtazapine Oral Disintegrating Tablets, Teva Pharma, Approval | Mirtazapine Orally Disintegrating Tablets, Amide Pharma, Approval | Mirtazapine Orally Disintegrating Tablets, Aurobindo Pharma, Approval & Tentative Approval | Mirtazapine Orally Disintegrating Tablets, Barr Laboratories, New Strength (45mg) | Mirtazapine Orally Disintegrating Tablets, Aurobindo Pharma, Approval | Remeron (mirtazapine) Tablets, Organon Inc., Labeling Revision | Remeron SolTab (mirtazapine) Orally Disintegrating Tablets, Organon Inc., Labeling Revision | Mirtazapine Orally Disintegrating Tablets, Actavis Elizabeth, Tentative Approval | Remeron (mirtazapine) Tablets, Organon Inc., Labeling Revision | Remeron SolTab (mirtazapine) Orally Disintegrating Tablets, Organon Inc., Labeling Revision | Mirtazapine Orally Disintegrating Tablets, Actavis Elizabeth LLC, Approval | Mirtazapine Orally Disintegrating Tablets, Actavis Elizabeth LLC, Approval | Remeron, mirtazapine, Tablet; Oral, Organon Usa Inc, Labeling Revision ^ 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