Details for New Drug Application (NDA): 218531
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NDA 218531 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 twenty-nine 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 218531
| Tradename: | ENALAPRIL MALEATE |
| Applicant: | Unique Pharm |
| Ingredient: | enalapril maleate |
| Patents: | 0 |
Pharmacology for NDA: 218531
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 218531
Suppliers and Packaging for NDA: 218531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 218531 | ANDA | Rising Pharma Holdings, Inc. | 64980-685 | 64980-685-01 | 100 TABLET in 1 BOTTLE (64980-685-01) |
| ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 218531 | ANDA | Rising Pharma Holdings, Inc. | 64980-685 | 64980-685-10 | 1000 TABLET in 1 BOTTLE (64980-685-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Sep 19, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 19, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 19, 2024 | TE: | AB | RLD: | No | ||||
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