Details for New Drug Application (NDA): 079133
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NDA 079133 describes AMILORIDE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Endo Operations, Sigmapharm Labs Llc, Barr, Rising, Teva, and Watson Labs, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the AMILORIDE HYDROCHLORIDE profile page.
The generic ingredient in AMILORIDE HYDROCHLORIDE is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.
The generic ingredient in AMILORIDE HYDROCHLORIDE is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.
Summary for 079133
| Tradename: | AMILORIDE HYDROCHLORIDE |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | amiloride hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 079133
| Physiological Effect | Decreased Renal K+ Excretion Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 079133
Suppliers and Packaging for NDA: 079133
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE | amiloride hydrochloride | TABLET;ORAL | 079133 | ANDA | Sigmapharm Laboratories, LLC | 42794-005 | 42794-005-02 | 100 TABLET in 1 BOTTLE (42794-005-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 30, 2009 | TE: | AB | RLD: | No | ||||
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