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Details for New Drug Application (NDA): 021779
NDA 021779 describes VENTAVIS, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the VENTAVIS profile page.
The generic ingredient in VENTAVIS is iloprost. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iloprost profile page.
The generic ingredient in VENTAVIS is iloprost. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iloprost profile page.
Summary for 021779
| Tradename: | VENTAVIS |
| Applicant: | Actelion Pharms Ltd |
| Ingredient: | iloprost |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021779
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VENTAVIS | iloprost | SOLUTION;INHALATION | 021779 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-302 | 66215-302-30 | 30 AMPULE in 1 CARTON (66215-302-30) > 1 mL in 1 AMPULE (66215-302-00) |
| VENTAVIS | iloprost | SOLUTION;INHALATION | 021779 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-303 | 66215-303-30 | 30 AMPULE in 1 CARTON (66215-303-30) > 1 mL in 1 AMPULE (66215-303-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | 20MCG/2ML (10MCG/ML) | ||||
| Approval Date: | Dec 29, 2004 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 10MCG/ML (10MCG/ML) | ||||
| Approval Date: | Dec 8, 2005 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 20MCG/ML (20MCG/ML) | ||||
| Approval Date: | Aug 7, 2009 | TE: | RLD: | Yes | |||||
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