| NDC Code | 68083-513-10 |
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| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01) |
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| Product NDC | 68083-513 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Erythromycin Lactobionate |
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| Non-Proprietary Name | Erythromycin Lactobionate |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20241119 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA216761 |
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| Manufacturer | Gland Pharma Limited |
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| Substance Name | ERYTHROMYCIN LACTOBIONATE |
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| Strength | 500 |
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| Strength Unit | mg/10mL |
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| Pharmacy Classes | Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS] |
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