Details for New Drug Application (NDA): 020415
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The generic ingredient in REMERON is mirtazapine. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 020415
Tradename: | REMERON |
Applicant: | Organon Usa Inc |
Ingredient: | mirtazapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 14, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Jun 14, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 45MG | ||||
Approval Date: | Mar 17, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 020415
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Usa Inc | REMERON | mirtazapine | TABLET;ORAL | 020415-001 | Jun 14, 1996 | See Plans and Pricing | See Plans and Pricing |
Organon Usa Inc | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | See Plans and Pricing | See Plans and Pricing |
Organon Usa Inc | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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