| NDC Code | 68180-828-09 |
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| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (68180-828-09) |
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| Product NDC | 68180-828 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Fyavolv |
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| Non-Proprietary Name | Norethindrone Acetate And Ethinyl Estradiol |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20160315 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA204213 |
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| Manufacturer | Lupin Pharmaceuticals, Inc. |
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| Substance Name | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
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| Strength | .005; 1 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
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