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Details for New Drug Application (NDA): 020415
» See Plans and Pricing
NDA 020415 describes REMERON, which is a drug marketed by Organon Usa Inc and is included in two NDAs. It is available from one supplier. 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-one 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-one 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 |
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 | Organon USA Inc. | 0052-0105 | 0052-0105-30 | 1 BOTTLE in 1 CARTON (0052-0105-30) > 30 TABLET, FILM COATED in 1 BOTTLE |
| REMERON | mirtazapine | TABLET;ORAL | 020415 | NDA | Organon USA Inc. | 0052-0107 | 0052-0107-30 | 1 BOTTLE in 1 CARTON (0052-0107-30) > 30 TABLET, FILM COATED in 1 BOTTLE |
Paragraph IV (Patent) Challenges for 020415
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| REMERON | TABLET;ORAL | mirtazapine | 020415 |
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| DISCN | Dosage: | TABLET;ORAL | Strength | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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 Usa Inc | REMERON | mirtazapine | TABLET;ORAL | 020415-003 | Mar 17, 1997 | Get Started for $10 | Get Started for $10 |
| Organon Usa Inc | REMERON | mirtazapine | TABLET;ORAL | 020415-001 | Jun 14, 1996 | Get Started for $10 | Get Started for $10 |
| Organon Usa Inc | REMERON | mirtazapine | TABLET;ORAL | 020415-002 | Jun 14, 1996 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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