Details for New Drug Application (NDA): 213806
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The generic ingredient in PENTAMIDINE ISETHIONATE 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 213806
Tradename: | PENTAMIDINE ISETHIONATE |
Applicant: | Avet Lifesciences |
Ingredient: | pentamidine isethionate |
Patents: | 0 |
Suppliers and Packaging for NDA: 213806
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PENTAMIDINE ISETHIONATE | pentamidine isethionate | INJECTABLE;INJECTION | 213806 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-748 | 23155-748-41 | 10 VIAL, SINGLE-DOSE in 1 CARTON (23155-748-41) / 300 mg in 1 VIAL, SINGLE-DOSE (23155-748-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/VIAL | ||||
Approval Date: | Jan 7, 2021 | TE: | AP | RLD: | No |
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