DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 040750
NDA 040750 describes SPIRONOLACTONE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma Ltd, Casi Pharms Inc, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Vintage, Warner Chilcott, Watson Labs, Yaopharma Co Ltd, Parke Davis, and Usl Pharma, and is included in thirty-nine NDAs. It is available from thirty-four suppliers. Additional details are available on the SPIRONOLACTONE profile page.
The generic ingredient in SPIRONOLACTONE 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 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 040750
| Tradename: | SPIRONOLACTONE |
| Applicant: | Vintage |
| Ingredient: | spironolactone |
| Patents: | 0 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040750
| Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 040750
Suppliers and Packaging for NDA: 040750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040750 | ANDA | Par Pharmaceutical | 0603-5763 | N | 0603-5763-28 |
| SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040750 | ANDA | Par Pharmaceutical | 0603-5763 | N | 0603-5763-32 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 29, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 29, 2006 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 29, 2006 | TE: | AB | RLD: | No | ||||
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