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. 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 |
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| DISCN | Dosage: | TABLET;ORAL | Strength | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | 020415-001 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Organon | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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