Details for New Drug Application (NDA): 050558
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NDA 050558 describes ZINACEF, which is a drug marketed by Pai Holdings Pharm and is included in two NDAs. Additional details are available on the ZINACEF profile page.
The generic ingredient in ZINACEF is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
The generic ingredient in ZINACEF is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 050558
| Tradename: | ZINACEF |
| Applicant: | Pai Holdings Pharm |
| Ingredient: | cefuroxime sodium |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 750MG BASE/VIAL | ||||
| Approval Date: | Oct 19, 1983 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5GM BASE/VIAL | ||||
| Approval Date: | Oct 19, 1983 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 7.5GM BASE/VIAL | ||||
| Approval Date: | Oct 23, 1986 | TE: | RLD: | Yes | |||||
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