Details for New Drug Application (NDA): 019887
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NDA 019887 describes NEBUPENT, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the NEBUPENT profile page.
The generic ingredient in NEBUPENT is pentamidine isethionate. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentamidine isethionate profile page.
The generic ingredient in NEBUPENT is pentamidine isethionate. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentamidine isethionate profile page.
Summary for 019887
| Tradename: | NEBUPENT |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | pentamidine isethionate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019887
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEBUPENT | pentamidine isethionate | FOR SOLUTION;INHALATION | 019887 | NDA | Fresenius Kabi USA, LLC | 63323-877 | 63323-877-15 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INHALATION | Strength | 300MG/VIAL | ||||
| Approval Date: | Jun 15, 1989 | TE: | AN | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;INHALATION | Strength | 600MG/VIAL | ||||
| Approval Date: | Mar 22, 1996 | TE: | RLD: | No | |||||
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