Details for New Drug Application (NDA): 207613
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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 207613
Tradename: | MIDODRINE HYDROCHLORIDE |
Applicant: | Thinq Pharm-cro Pvt |
Ingredient: | midodrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207613
Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 207613
Suppliers and Packaging for NDA: 207613
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 207613 | ANDA | Rising Pharmaceuticals, Inc. | 64980-433 | 64980-433-01 | 100 TABLET in 1 BOTTLE (64980-433-01) |
MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 207613 | ANDA | Rising Pharmaceuticals, Inc. | 64980-434 | 64980-434-01 | 100 TABLET in 1 BOTTLE (64980-434-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 2, 2018 | TE: | AB | RLD: | No |
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