Details for New Drug Application (NDA): 076725
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The generic ingredient in ORVATEN is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
Summary for 076725
Tradename: | ORVATEN |
Applicant: | Upsher Smith Labs |
Ingredient: | midodrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076725
Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 076725
Suppliers and Packaging for NDA: 076725
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ORVATEN | midodrine hydrochloride | TABLET;ORAL | 076725 | ANDA | Upsher-Smith laboratories, LLC | 0245-0211 | 0245-0211-01 | 100 BLISTER PACK in 1 CARTON (0245-0211-01) / 1 TABLET in 1 BLISTER PACK (0245-0211-89) |
ORVATEN | midodrine hydrochloride | TABLET;ORAL | 076725 | ANDA | Upsher-Smith laboratories, LLC | 0245-0211 | 0245-0211-11 | 100 TABLET in 1 BOTTLE (0245-0211-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Nov 3, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 3, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 3, 2004 | TE: | AB | RLD: | No |
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