Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021208

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REMERON SOLTAB (MIRTAZAPINE)
15MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: REMERON SOLTAB
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021208
Product Number: 001
Approval Date: Jan 12, 2001
Applicant Holder Full Name: ORGANON USA LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

REMERON SOLTAB (MIRTAZAPINE)
30MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: REMERON SOLTAB
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021208
Product Number: 002
Approval Date: Jan 12, 2001
Applicant Holder Full Name: ORGANON USA LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

REMERON SOLTAB (MIRTAZAPINE)
45MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: REMERON SOLTAB
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021208
Product Number: 003
Approval Date: Jan 12, 2001
Applicant Holder Full Name: ORGANON USA LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information