Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076921

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MIRTAZAPINE (MIRTAZAPINE)
7.5MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: MIRTAZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076921
Product Number: 001
Approval Date: Oct 22, 2004
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRTAZAPINE (MIRTAZAPINE)
15MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: MIRTAZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076921
Product Number: 002
Approval Date: Oct 22, 2004
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRTAZAPINE (MIRTAZAPINE)
30MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: MIRTAZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076921
Product Number: 003
Approval Date: Oct 22, 2004
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRTAZAPINE (MIRTAZAPINE)
45MG
Marketing Status: Prescription

Active Ingredient: MIRTAZAPINE
Proprietary Name: MIRTAZAPINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 45MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076921
Product Number: 004
Approval Date: Oct 22, 2004
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information