DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 040750
» See Plans and Pricing
NDA 040750 describes SPIRONOLACTONE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma Ltd, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Yaopharma Co Ltd, Parke Davis, and Usl Pharma, and is included in forty 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 040750
| Tradename: | SPIRONOLACTONE |
| Applicant: | Oxford Pharms |
| Ingredient: | spironolactone |
| Patents: | 0 |
| 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 | 0603-5763-21 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-21) |
| SPIRONOLACTONE | spironolactone | TABLET;ORAL | 040750 | ANDA | Par Pharmaceutical | 0603-5763 | 0603-5763-28 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-28) |
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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