Details for New Drug Application (NDA): 076122
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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 076122
Tradename: | MIRTAZAPINE |
Applicant: | Mylan |
Ingredient: | mirtazapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 076122
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076122 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3515 | 0378-3515-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-01) |
MIRTAZAPINE | mirtazapine | TABLET;ORAL | 076122 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3515 | 0378-3515-10 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3515-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 19, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Jun 19, 2003 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 45MG | ||||
Approval Date: | Jun 19, 2003 | TE: | AB | RLD: | No |
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