Details for New Drug Application (NDA): 075909
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NDA 075909 describes ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE 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 AND HYDROCHLOROTHIAZIDE 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 075909
| Tradename: | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | enalapril maleate; hydrochlorothiazide |
| Patents: | 0 |
Pharmacology for NDA: 075909
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Suppliers and Packaging for NDA: 075909
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 075909 | ANDA | Dr. Reddy's Laboratories Limited | 55111-133 | 55111-133-01 | 100 TABLET in 1 BOTTLE (55111-133-01) |
| ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 075909 | ANDA | Dr. Reddy's Laboratories Limited | 55111-133 | 55111-133-10 | 1000 TABLET in 1 BOTTLE (55111-133-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;12.5MG | ||||
| Approval Date: | Oct 15, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;25MG | ||||
| Approval Date: | Oct 15, 2001 | TE: | AB | RLD: | No | ||||
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