Details for New Drug Application (NDA): 091604
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NDA 091604 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 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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