Details for New Drug Application (NDA): 090697
✉ Email this page to a colleague
NDA 090697 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 090697
| Tradename: | RAMIPRIL |
| Applicant: | Zydus Pharms Usa Inc |
| Ingredient: | ramipril |
| Patents: | 0 |
Pharmacology for NDA: 090697
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 090697
Suppliers and Packaging for NDA: 090697
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAMIPRIL | ramipril | TABLET;ORAL | 090697 | ANDA | Zydus Lifesciences Limited | 65841-699 | 65841-699-01 | 100 TABLET in 1 BOTTLE (65841-699-01) |
| RAMIPRIL | ramipril | TABLET;ORAL | 090697 | ANDA | Zydus Lifesciences Limited | 65841-699 | 65841-699-05 | 500 TABLET in 1 BOTTLE (65841-699-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
| Approval Date: | Sep 24, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Sep 24, 2009 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 24, 2009 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
