Details for New Drug Application (NDA): 019264
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The generic ingredient in PENTAM 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 019264
Tradename: | PENTAM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | pentamidine isethionate |
Patents: | 0 |
Suppliers and Packaging for NDA: 019264
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PENTAM | pentamidine isethionate | INJECTABLE;INJECTION | 019264 | NDA | Fresenius Kabi USA, LLC | 63323-113 | 63323-113-10 | 10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/VIAL | ||||
Approval Date: | Oct 16, 1984 | TE: | AP | RLD: | Yes |
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