Details for New Drug Application (NDA): 205798
✉ Email this page to a colleague
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 205798
Tradename: | MIRTAZAPINE |
Applicant: | Square Pharms |
Ingredient: | mirtazapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 205798
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 205798 | ANDA | Bryant Ranch Prepack | 71335-2471 | 71335-2471-1 | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2471-1) |
MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 205798 | ANDA | Viona Pharmaceuticals Inc. | 72578-103 | 72578-103-84 | 5 BLISTER PACK in 1 CARTON (72578-103-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 1, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 30MG | ||||
Approval Date: | Jun 1, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 45MG | ||||
Approval Date: | Jun 1, 2017 | TE: | AB | RLD: | No |
Complete Access Available with Subscription