Details for New Drug Application (NDA): 018200
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NDA 018200 describes MIDAMOR, which is a drug marketed by Padagis Us and is included in one NDA. It is available from one supplier. Additional details are available on the MIDAMOR profile page.
The generic ingredient in MIDAMOR is amiloride hydrochloride. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride profile page.
The generic ingredient in MIDAMOR is amiloride hydrochloride. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride profile page.
Summary for 018200
| Tradename: | MIDAMOR |
| Applicant: | Padagis Us |
| Ingredient: | amiloride hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018200
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 018200
Suppliers and Packaging for NDA: 018200
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIDAMOR | amiloride hydrochloride | TABLET;ORAL | 018200 | NDA | Padagis US LLC | 0574-0292 | 0574-0292-01 | 100 TABLET in 1 BOTTLE (0574-0292-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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