Details for New Drug Application (NDA): 077376
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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 077376
Tradename: | MIRTAZAPINE |
Applicant: | Aurobindo Pharma |
Ingredient: | mirtazapine |
Patents: | 0 |
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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