| NDC Code | 43386-543-05 |
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| Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-05) |
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| Product NDC | 43386-543 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Morphine Sulfate |
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| Non-Proprietary Name | Morphine Sulfate |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20151216 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA203602 |
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| Manufacturer | Lupin Pharmaceuticals,Inc. |
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| Substance Name | MORPHINE SULFATE |
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| Strength | 100 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
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| DEA Schedule | CII |
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