Details for New Drug Application (NDA): 075483
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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 075483
Tradename: | ENALAPRIL MALEATE |
Applicant: | Wockhardt Ltd |
Ingredient: | enalapril maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075483
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 075483
Suppliers and Packaging for NDA: 075483
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075483 | ANDA | Major Pharmaceuticals | 0904-5502 | 0904-5502-61 | 100 BLISTER PACK in 1 CARTON (0904-5502-61) / 1 TABLET in 1 BLISTER PACK |
ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075483 | ANDA | Major Pharmaceuticals | 0904-5609 | 0904-5609-61 | 100 BLISTER PACK in 1 CARTON (0904-5609-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Aug 22, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 22, 2000 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 22, 2000 | TE: | AB | RLD: | No |
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