Details for New Drug Application (NDA): 078687
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NDA 078687 describes ENALAPRILAT, which is a drug marketed by Chartwell Injectable, Dr Reddys, Hikma Farmaceutica, and Hospira, and is included in six NDAs. It is available from three suppliers. Additional details are available on the ENALAPRILAT profile page.
The generic ingredient in ENALAPRILAT is enalaprilat. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalaprilat profile page.
The generic ingredient in ENALAPRILAT is enalaprilat. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalaprilat profile page.
Summary for 078687
| Tradename: | ENALAPRILAT |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | enalaprilat |
| Patents: | 0 |
Pharmacology for NDA: 078687
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 078687
Suppliers and Packaging for NDA: 078687
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENALAPRILAT | enalaprilat | INJECTABLE;INJECTION | 078687 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9786 | 0143-9786-10 | 10 VIAL in 1 CARTON (0143-9786-10) / 2 mL in 1 VIAL (0143-9786-01) |
| ENALAPRILAT | enalaprilat | INJECTABLE;INJECTION | 078687 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9787 | 0143-9787-10 | 10 VIAL in 1 CARTON (0143-9787-10) / 1 mL in 1 VIAL (0143-9787-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1.25MG/ML | ||||
| Approval Date: | Dec 23, 2008 | TE: | AP | RLD: | No | ||||
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