Details for New Drug Application (NDA): 016224
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NDA 016224 describes ROBENGATOPE, which is a drug marketed by Bracco and is included in one NDA. Additional details are available on the ROBENGATOPE profile page.
The generic ingredient in ROBENGATOPE is rose bengal sodium i-131. There are one hundred and four drug master file entries for this compound. Additional details are available on the rose bengal sodium i-131 profile page.
The generic ingredient in ROBENGATOPE is rose bengal sodium i-131. There are one hundred and four drug master file entries for this compound. Additional details are available on the rose bengal sodium i-131 profile page.
Summary for 016224
| Tradename: | ROBENGATOPE |
| Applicant: | Bracco |
| Ingredient: | rose bengal sodium i-131 |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 016224
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.5mCi/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1mCi/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2mCi/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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