Details for New Drug Application (NDA): 206983
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NDA 206983 describes PENTAMIDINE ISETHIONATE, which is a drug marketed by Seton Pharms, X-gen Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Hospira, Watson Labs, and Xgen Pharms, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the PENTAMIDINE ISETHIONATE profile page.
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.
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 206983
| Tradename: | PENTAMIDINE ISETHIONATE |
| Applicant: | X-gen Pharms Inc |
| Ingredient: | pentamidine isethionate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTAMIDINE ISETHIONATE | pentamidine isethionate | FOR SOLUTION;INHALATION | 206983 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-3030 | 39822-3030-2 | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;INHALATION | Strength | 300MG/VIAL | ||||
| Approval Date: | Jan 20, 2023 | TE: | AN | RLD: | No | ||||
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