Details for New Drug Application (NDA): 211973
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The generic ingredient in MIDODRINE HYDROCHLORIDE 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 211973
Tradename: | MIDODRINE HYDROCHLORIDE |
Applicant: | Novugen |
Ingredient: | midodrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211973
Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 211973
Suppliers and Packaging for NDA: 211973
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 211973 | ANDA | Novugen Pharma (USA) LLC | 82293-003 | 82293-003-10 | 100 TABLET in 1 BOTTLE (82293-003-10) |
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 211973 | ANDA | Novugen Pharma (USA) LLC | 82293-004 | 82293-004-10 | 100 TABLET in 1 BOTTLE (82293-004-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Oct 17, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 17, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 17, 2023 | TE: | AB | RLD: | No |
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