Details for New Drug Application (NDA): 216751
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NDA 216751 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-four 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-five 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-five suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 216751
| Tradename: | MIRTAZAPINE |
| Applicant: | Prasco |
| Ingredient: | mirtazapine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216751
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | mirtazapine | TABLET;ORAL | 216751 | ANDA | Prasco Laboratories | 66993-606 | 66993-606-04 | 500 TABLET, FILM COATED in 1 BOTTLE (66993-606-04) |
| MIRTAZAPINE | mirtazapine | TABLET;ORAL | 216751 | ANDA | Prasco Laboratories | 66993-606 | 66993-606-30 | 30 TABLET, FILM COATED in 1 BOTTLE (66993-606-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Jan 18, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Jan 18, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 18, 2023 | TE: | AB | RLD: | No | ||||
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