Details for New Drug Application (NDA): 213714
✉ Email this page to a colleague
The generic ingredient in ENALAPRIL MALEATE 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 213714
Tradename: | ENALAPRIL MALEATE |
Applicant: | Alkem Labs Ltd |
Ingredient: | enalapril maleate |
Patents: | 0 |
Pharmacology for NDA: 213714
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 213714
Suppliers and Packaging for NDA: 213714
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | enalapril maleate | SOLUTION;ORAL | 213714 | ANDA | Ascend Laboratories, LLC | 67877-712 | 67877-712-81 | 150 mL in 1 BOTTLE (67877-712-81) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Mar 30, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription