Details for New Drug Application (NDA): 050298
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NDA 050298 describes PYOPEN, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the PYOPEN profile page.
The generic ingredient in PYOPEN 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 PYOPEN 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 050298
| Tradename: | PYOPEN |
| Applicant: | Glaxosmithkline |
| 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 2GM BASE/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 | EQ 5GM BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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