Details for New Drug Application (NDA): 218085
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NDA 218085 describes SPIRONOLACTONE, which is a drug marketed by Amneal, Hetero Labs Ltd Iii, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Annora Pharma, Ascot, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Pharmobedient, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Parke Davis, and Usl Pharma, and is included in forty-four NDAs. It is available from thirty-eight 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 218085
| Tradename: | SPIRONOLACTONE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | spironolactone |
| Patents: | 0 |
Pharmacology for NDA: 218085
| Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 218085
Suppliers and Packaging for NDA: 218085
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE | spironolactone | SUSPENSION;ORAL | 218085 | ANDA | Camber Pharmaceuticals, Inc. | 31722-691 | 31722-691-11 | 118 mL in 1 BOTTLE (31722-691-11) |
| SPIRONOLACTONE | spironolactone | SUSPENSION;ORAL | 218085 | ANDA | Camber Pharmaceuticals, Inc. | 31722-691 | 31722-691-47 | 473 mL in 1 BOTTLE (31722-691-47) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
| Approval Date: | Feb 21, 2025 | TE: | AB | RLD: | No | ||||
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