DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 077746
The generic ingredient in MIDODRINE HYDROCHLORIDE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 077746
Tradename: | MIDODRINE HYDROCHLORIDE |
Applicant: | Apotex Inc |
Ingredient: | midodrine hydrochloride |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077746
Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 077746
Suppliers and Packaging for NDA: 077746
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 077746 | ANDA | AvKARE, Inc. | 42291-560 | N | 42291-560-90 |
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 077746 | ANDA | AvKARE, Inc. | 42291-561 | N | 42291-561-90 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Sep 12, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 12, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 12, 2006 | TE: | AB | RLD: | No |
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