Details for New Drug Application (NDA): 075578
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NDA 075578 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 075578
| Tradename: | ENALAPRILAT |
| Applicant: | Dr Reddys |
| Ingredient: | enalaprilat |
| Patents: | 0 |
Pharmacology for NDA: 075578
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 075578
Suppliers and Packaging for NDA: 075578
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENALAPRILAT | enalaprilat | INJECTABLE;INJECTION | 075578 | ANDA | Dr. Reddys Laboratories Inc | 43598-078 | 43598-078-58 | 10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11) |
| ENALAPRILAT | enalaprilat | INJECTABLE;INJECTION | 075578 | ANDA | Dr. Reddys Laboratories Inc | 43598-169 | 43598-169-58 | 10 VIAL in 1 CARTON (43598-169-58) / 2 mL in 1 VIAL (43598-169-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1.25MG/ML | ||||
| Approval Date: | Aug 22, 2000 | TE: | AP | RLD: | No | ||||
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