Details for New Drug Application (NDA): 086513
✉ Email this page to a colleague
NDA 086513 describes SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, and Watson Labs, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 086513
| Tradename: | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Mylan |
| Ingredient: | hydrochlorothiazide; spironolactone |
| Patents: | 0 |
Pharmacology for NDA: 086513
| Mechanism of Action | Aldosterone Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 086513
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 086513 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0403 | 0378-0403-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01) |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; spironolactone | TABLET;ORAL | 086513 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0403 | 0378-0403-05 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0403-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
