Details for New Drug Application (NDA): 212894
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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 212894
Tradename: | ENALAPRIL MALEATE |
Applicant: | Amneal |
Ingredient: | enalapril maleate |
Patents: | 0 |
Pharmacology for NDA: 212894
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 212894
Suppliers and Packaging for NDA: 212894
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | enalapril maleate | SOLUTION;ORAL | 212894 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1729 | 69238-1729-7 | 1 BOTTLE in 1 CARTON (69238-1729-7) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Jun 29, 2022 | TE: | AB | RLD: | No |
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