Details for New Drug Application (NDA): 076921
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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 076921
Tradename: | MIRTAZAPINE |
Applicant: | Aurobindo |
Ingredient: | mirtazapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 076921
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076921 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8268 | 0615-8268-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-05) |
MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076921 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8268 | 0615-8268-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8268-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Oct 22, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Oct 22, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Oct 22, 2004 | TE: | AB | RLD: | No |
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