| NDC Code | 68083-680-01 |
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| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (68083-680-01) / 15 mL in 1 BOTTLE, DROPPER |
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| Product NDC | 68083-680 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Phenylephrine Hydrochloride |
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| Non-Proprietary Name | Phenylephrine Hydrochloride |
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| Dosage Form | SOLUTION/ DROPS |
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| Usage | OPHTHALMIC |
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| Start Marketing Date | 20250917 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA218129 |
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| Manufacturer | Gland Pharma Limited |
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| Substance Name | PHENYLEPHRINE HYDROCHLORIDE |
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| Strength | 25 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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