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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
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