Details for New Drug Application (NDA): 050643
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NDA 050643 describes ZINACEF IN PLASTIC CONTAINER, which is a drug marketed by Pai Holdings Pharm and is included in one NDA. Additional details are available on the ZINACEF IN PLASTIC CONTAINER profile page.
The generic ingredient in ZINACEF IN PLASTIC CONTAINER is cefuroxime sodium. There is one drug master file entry 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 IN PLASTIC CONTAINER is cefuroxime sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 050643
| Tradename: | ZINACEF IN PLASTIC CONTAINER |
| Applicant: | Pai Holdings Pharm |
| Ingredient: | cefuroxime sodium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 15MG BASE/ML | ||||
| Approval Date: | Apr 28, 1989 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30MG BASE/ML | ||||
| Approval Date: | Apr 28, 1989 | TE: | RLD: | Yes | |||||
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