Details for New Drug Application (NDA): 017057
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NDA 017057 describes CYSTO-CONRAY II, which is a drug marketed by Liebel-flarsheim and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTO-CONRAY II profile page.
The generic ingredient in CYSTO-CONRAY II is iothalamate meglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate meglumine profile page.
The generic ingredient in CYSTO-CONRAY II is iothalamate meglumine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate meglumine profile page.
Summary for 017057
| Tradename: | CYSTO-CONRAY II |
| Applicant: | Liebel-flarsheim |
| Ingredient: | iothalamate meglumine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 017057
| Mechanism of Action | X-Ray Contrast Activity |
Medical Subject Heading (MeSH) Categories for 017057
Suppliers and Packaging for NDA: 017057
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYSTO-CONRAY II | iothalamate meglumine | SOLUTION;INTRAVESICAL | 017057 | NDA | Liebel-Flarsheim Company LLC | 0019-0862 | 0019-0862-50 | 12 BOTTLE, GLASS in 1 BOX (0019-0862-50) / 250 mL in 1 BOTTLE, GLASS |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVESICAL | Strength | 17.2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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