Details for New Drug Application (NDA): 212543
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NDA 212543 describes MIDODRINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Rubicon, Thinq Pharm-cro Pvt, Xiromed, and Zydus Lifesciences, and is included in thirteen NDAs. It is available from twenty-nine 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. Thirty 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. Thirty 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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