Details for New Drug Application (NDA): 078832
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NDA 078832 describes RAMIPRIL, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Cipla, Corepharma, Dr Reddys Labs Ltd, Hikma, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, Zydus Pharms Usa, Apotex, Natco Pharma, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from seventeen suppliers. Additional details are available on the RAMIPRIL profile page.
The generic ingredient in RAMIPRIL is ramipril. There are nineteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.
The generic ingredient in RAMIPRIL is ramipril. There are nineteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 078832
| Tradename: | RAMIPRIL |
| Applicant: | Zydus Pharms Usa |
| Ingredient: | ramipril |
| Patents: | 0 |
Pharmacology for NDA: 078832
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 078832
Suppliers and Packaging for NDA: 078832
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAMIPRIL | ramipril | CAPSULE;ORAL | 078832 | ANDA | Zydus Lifesciences Limited | 65841-655 | 65841-655-01 | 100 CAPSULE in 1 BOTTLE (65841-655-01) |
| RAMIPRIL | ramipril | CAPSULE;ORAL | 078832 | ANDA | Zydus Lifesciences Limited | 65841-655 | 65841-655-05 | 500 CAPSULE in 1 BOTTLE (65841-655-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1.25MG | ||||
| Approval Date: | Sep 2, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Sep 2, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 2, 2008 | TE: | AB | RLD: | No | ||||
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