Details for New Drug Application (NDA): 203512
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NDA 203512 describes SPIRONOLACTONE, which is a drug marketed by Amneal, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Ascot, Aurobindo Pharma, Chartwell Rx, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Norvium Bioscience, Oxford Pharms, 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-one NDAs. It is available from forty 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.
Summary for 203512
| Tradename: | SPIRONOLACTONE |
| Applicant: | Accord Hlthcare |
| Ingredient: | spironolactone |
| Patents: | 0 |
Pharmacology for NDA: 203512
| Mechanism of Action | Aldosterone Antagonists |
Medical Subject Heading (MeSH) Categories for 203512
Suppliers and Packaging for NDA: 203512
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SPIRONOLACTONE | spironolactone | TABLET;ORAL | 203512 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8178 | 0615-8178-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8178-05) |
| SPIRONOLACTONE | spironolactone | TABLET;ORAL | 203512 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8178 | 0615-8178-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8178-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 19, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 19, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Sep 19, 2016 | TE: | AB | RLD: | No | ||||
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