Details for New Drug Application (NDA): 050306
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NDA 050306 describes GEOPEN, which is a drug marketed by Roerig and is included in one NDA. Additional details are available on the GEOPEN profile page.
The generic ingredient in GEOPEN is carbenicillin disodium. There are three drug master file entries for this compound. Additional details are available on the carbenicillin disodium profile page.
The generic ingredient in GEOPEN is carbenicillin disodium. There are three drug master file entries for this compound. Additional details are available on the carbenicillin disodium profile page.
Summary for 050306
| Tradename: | GEOPEN |
| Applicant: | Roerig |
| Ingredient: | carbenicillin disodium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/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 | EQ 5GM BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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