Details for New Drug Application (NDA): 020415
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NDA 020415 describes REMERON, which is a drug marketed by Organon and Organon Usa Organon and is included in two NDAs. It is available from two suppliers. Additional details are available on the REMERON profile page.
The generic ingredient in REMERON is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
The generic ingredient in REMERON is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 020415
| Tradename: | REMERON |
| Applicant: | Organon |
| Ingredient: | mirtazapine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020415
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REMERON | mirtazapine | TABLET;ORAL | 020415 | NDA | REMEDYREPACK INC. | 70518-3955 | 70518-3955-0 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3955-0) |
| REMERON | mirtazapine | TABLET;ORAL | 020415 | NDA | Organon LLC | 78206-160 | 78206-160-01 | 1 BOTTLE in 1 CARTON (78206-160-01) / 30 TABLET, FILM COATED in 1 BOTTLE |
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| DISCN | Dosage: | TABLET;ORAL | Strength | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| 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 | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-001 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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