Details for New Drug Application (NDA): 212543
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The generic ingredient in MIDODRINE HYDROCHLORIDE 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 212543
Tradename: | MIDODRINE HYDROCHLORIDE |
Applicant: | Rubicon |
Ingredient: | midodrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212543
Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 212543
Suppliers and Packaging for NDA: 212543
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 212543 | ANDA | TruPharma, LLC | 52817-323 | 52817-323-10 | 100 TABLET in 1 BOTTLE (52817-323-10) |
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 212543 | ANDA | TruPharma, LLC | 52817-324 | 52817-324-10 | 100 TABLET in 1 BOTTLE (52817-324-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No |
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