"83107-022-04" National Drug Code (NDC)

Pramosone 118 mL in 1 BOTTLE (83107-022-04)
(Legacy Pharma USA Inc.)

NDC Code83107-022-04
Package Description118 mL in 1 BOTTLE (83107-022-04)
Product NDC83107-022
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePramosone
Non-Proprietary NameHydrocortisone Acetate And Pramoxine Hydrochloride
Dosage FormLOTION
UsageTOPICAL
Start Marketing Date20250606
Marketing Category NameANDA
Application NumberANDA085980
ManufacturerLegacy Pharma USA Inc.
Substance NameHYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Strength10; 10
Strength Unitmg/mL; mg/mL
Pharmacy ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]

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