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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
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