Details for New Drug Application (NDA): 216458
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NDA 216458 describes ENALAPRIL MALEATE, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Bionpharma, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Unique Pharm, Watson Labs, Wockhardt Ltd, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in thirty NDAs. It is available from thirty suppliers. Additional details are available on the ENALAPRIL MALEATE profile page.
The generic ingredient in ENALAPRIL MALEATE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
The generic ingredient in ENALAPRIL MALEATE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 216458
| Tradename: | ENALAPRIL MALEATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | enalapril maleate |
| Patents: | 0 |
Pharmacology for NDA: 216458
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 216458
Suppliers and Packaging for NDA: 216458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | enalapril maleate | SOLUTION;ORAL | 216458 | ANDA | Aurobindo Pharma Limited | 59651-529 | 59651-529-55 | 1 BOTTLE in 1 CARTON (59651-529-55) / 150 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Jan 8, 2024 | TE: | AB | RLD: | No | ||||
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