Details for New Drug Application (NDA): 211973
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NDA 211973 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-seven 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-eight 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-eight 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 | Coupler LLC | 67046-1404 | 67046-1404-3 | 30 TABLET in 1 BLISTER PACK (67046-1404-3) |
| 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) |
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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