Details for New Drug Application (NDA): 076116
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NDA 076116 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 076116
| Tradename: | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE |
| Applicant: | Chartwell Rx |
| Ingredient: | enalapril maleate; hydrochlorothiazide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;12.5MG | ||||
| Approval Date: | Sep 19, 2001 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG;25MG | ||||
| Approval Date: | Sep 19, 2001 | TE: | RLD: | No | |||||
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