Details for New Drug Application (NDA): 202586
NDA 202586 describes INDIUM IN 111 OXYQUINOLINE, which is a drug marketed by Bwxt Itg and Ge Healthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the INDIUM IN 111 OXYQUINOLINE profile page.
The generic ingredient in INDIUM IN 111 OXYQUINOLINE is indium in-111 oxyquinoline. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 oxyquinoline profile page.
The generic ingredient in INDIUM IN 111 OXYQUINOLINE is indium in-111 oxyquinoline. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 oxyquinoline profile page.
Summary for 202586
| Tradename: | INDIUM IN 111 OXYQUINOLINE |
| Applicant: | Bwxt Itg |
| Ingredient: | indium in-111 oxyquinoline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202586
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INDIUM IN 111 OXYQUINOLINE | indium in-111 oxyquinoline | INJECTABLE;INJECTION | 202586 | ANDA | BWXT Medical Ltd. | 72536-0920 | 72536-0920-1 | 1 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1mCi/ML | ||||
| Approval Date: | Jul 25, 2018 | TE: | AP | RLD: | No | ||||
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