Details for New Drug Application (NDA): 076725
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NDA 076725 describes ORVATEN, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the ORVATEN profile page.
The generic ingredient in ORVATEN is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.
The generic ingredient in ORVATEN is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-seven 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 |
| Formulation / Manufacturing: | see details |
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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