Details for New Drug Application (NDA): 076901
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The generic ingredient in MIRTAZAPINE is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 076901
Tradename: | MIRTAZAPINE |
Applicant: | Impax Labs Inc |
Ingredient: | mirtazapine |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 28, 2005 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 30MG | ||||
Approval Date: | Jun 28, 2005 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 45MG | ||||
Approval Date: | Jun 28, 2005 | TE: | RLD: | No |
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