Details for New Drug Application (NDA): 202392
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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 202392
Tradename: | RAMIPRIL |
Applicant: | Accord Hlthcare |
Ingredient: | ramipril |
Patents: | 0 |
Pharmacology for NDA: 202392
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 202392
Suppliers and Packaging for NDA: 202392
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RAMIPRIL | ramipril | CAPSULE;ORAL | 202392 | ANDA | Proficient Rx LP | 63187-644 | 63187-644-30 | 30 CAPSULE in 1 BOTTLE (63187-644-30) |
RAMIPRIL | ramipril | CAPSULE;ORAL | 202392 | ANDA | Proficient Rx LP | 63187-644 | 63187-644-60 | 60 CAPSULE in 1 BOTTLE (63187-644-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 1.25MG | ||||
Approval Date: | Apr 15, 2014 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
Approval Date: | Apr 15, 2014 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 15, 2014 | TE: | RLD: | No |
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