Details for New Drug Application (NDA): 205798
✉ Email this page to a colleague
NDA 205798 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, and Watson Labs, and is included in twenty-one NDAs. It is available from thirty-three suppliers. Additional details are available on the MIRTAZAPINE profile page.
The generic ingredient in MIRTAZAPINE 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 MIRTAZAPINE 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 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 | 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) |
| MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 205798 | ANDA | Viona Pharmaceuticals Inc. | 72578-104 | 72578-104-84 | 5 BLISTER PACK in 1 CARTON (72578-104-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-104-69) |
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
