Details for New Drug Application (NDA): 091604
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The generic ingredient in RAMIPRIL is ramipril. There are nineteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 091604
Tradename: | RAMIPRIL |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | ramipril |
Patents: | 0 |
Pharmacology for NDA: 091604
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 091604
Suppliers and Packaging for NDA: 091604
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RAMIPRIL | ramipril | CAPSULE;ORAL | 091604 | ANDA | Medsource Pharmaceuticals | 45865-443 | 45865-443-49 | 100 CAPSULE in 1 BOTTLE (45865-443-49) |
RAMIPRIL | ramipril | CAPSULE;ORAL | 091604 | ANDA | Medsource Pharmaceuticals | 45865-443 | 45865-443-60 | 60 CAPSULE in 1 BOTTLE (45865-443-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1.25MG | ||||
Approval Date: | Jun 8, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jun 8, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 8, 2011 | TE: | AB | RLD: | No |
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