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Details for New Drug Application (NDA): 021779
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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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