Details for New Drug Application (NDA): 077376
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NDA 077376 describes MIRTAZAPINE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Aiping Pharm Inc, Apotex Inc, Aurobindo, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, 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 077376
| Tradename: | MIRTAZAPINE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | mirtazapine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077376
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 077376 | ANDA | Cardinal Health 107, LLC | 55154-8335 | 55154-8335-6 | 1 BLISTER PACK in 1 BAG (55154-8335-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| MIRTAZAPINE | mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 077376 | ANDA | Rising Pharma Holdings, Inc. | 57237-011 | 57237-011-06 | 5 BLISTER PACK in 1 CARTON (57237-011-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
| Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 30MG | ||||
| Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 45MG | ||||
| Approval Date: | Feb 28, 2006 | TE: | AB | RLD: | No | ||||
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