Details for New Drug Application (NDA): 021208
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NDA 021208 describes REMERON SOLTAB, which is a drug marketed by Organon Usa Organon and is included in one NDA. It is available from one supplier. Additional details are available on the REMERON SOLTAB profile page.
The generic ingredient in REMERON SOLTAB 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 SOLTAB 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 021208
| Tradename: | REMERON SOLTAB |
| Applicant: | Organon Usa Organon |
| Ingredient: | mirtazapine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021208
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | NDA | Organon LLC | 78206-156 | 78206-156-01 | 5 BLISTER PACK in 1 BOX (78206-156-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-156-99) |
| REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | NDA | Organon LLC | 78206-158 | 78206-158-01 | 5 BLISTER PACK in 1 BOX (78206-158-01) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (78206-158-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | Jan 12, 2001 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 12, 2001 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 45MG | ||||
| Approval Date: | Jan 12, 2001 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021208
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-002 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-002 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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