DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075657
NDA 075657 describes ENALAPRIL MALEATE, which is a drug marketed by Apotex, Apothecon, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Teva, Watson Labs, Wockhardt Ltd, Apotex Inc, Dr Reddys Labs Ltd, G And W Labs Inc, Taro Pharm Inds, and Upsher-smith Labs, and is included in twenty-three NDAs. It is available from thirty-six 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 075657
| Tradename: | ENALAPRIL MALEATE |
| Applicant: | Taro |
| Ingredient: | enalapril maleate |
| Patents: | 0 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075657
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 075657
Suppliers and Packaging for NDA: 075657
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075657 | ANDA | Blenheim Pharmacal, Inc. | 10544-195 | E | 10544-195-90 |
| ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075657 | ANDA | Blenheim Pharmacal, Inc. | 10544-293 | E | 10544-293-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 23, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 23, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 23, 2001 | TE: | AB | RLD: | No | ||||
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