Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020415

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REMERON (MIRTAZAPINE)
15MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: REMERON
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020415
Product Number: 001
Approval Date: Jun 14, 1996
Applicant Holder Full Name: ORGANON USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REMERON (MIRTAZAPINE)
30MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: REMERON
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020415
Product Number: 002
Approval Date: Jun 14, 1996
Applicant Holder Full Name: ORGANON USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

REMERON (MIRTAZAPINE)
45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: MIRTAZAPINE
Proprietary Name: REMERON
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020415
Product Number: 003
Approval Date: Mar 17, 1997
Applicant Holder Full Name: ORGANON USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information