Details for New Drug Application (NDA): 214734
✉ Email this page to a colleague
NDA 214734 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Par Pharm Inc, Rubicon, Thinq Pharm-cro Pvt, Xiromed, and Zydus, and is included in thirteen NDAs. It is available from twenty-six suppliers. Additional details are available on the MIDODRINE HYDROCHLORIDE profile page.
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.
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 214734
| Tradename: | MIDODRINE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | midodrine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214734
| Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 214734
Suppliers and Packaging for NDA: 214734
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 214734 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8443 | 0615-8443-39 | 30 TABLET in 1 BLISTER PACK (0615-8443-39) |
| MIDODRINE HYDROCHLORIDE | midodrine hydrochloride | TABLET;ORAL | 214734 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8444 | 0615-8444-39 | 30 TABLET in 1 BLISTER PACK (0615-8444-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 21, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 21, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 21, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
