Details for New Drug Application (NDA): 021208
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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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-002 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-003 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Organon Usa Organon | REMERON SOLTAB | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208-001 | Jan 12, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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