| NDC Code | 59137-231-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 59137-231 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Gleolan |
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| Non-Proprietary Name | Aminolevulinic Acid Hydrochloride |
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| Dosage Form | POWDER, FOR SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20180414 |
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| Marketing Category Name | NDA |
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| Application Number | NDA208630 |
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| Manufacturer | Medexus Pharma, Inc. |
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| Substance Name | AMINOLEVULINIC ACID HYDROCHLORIDE |
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| Strength | 1500 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC], Porphyrin Precursor [EPC], Porphyrinogens [CS] |
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