Label: FLUOCINONIDE solution
- NDC Code(s): 70771-1375-3, 70771-1375-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 26, 2022
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- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
FLUOCINONIDE
fluocinonide solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1375 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN) FLUOCINONIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1375-8 20 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 2 NDC:70771-1375-3 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208948 11/01/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (650650802) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1375) , MANUFACTURE(70771-1375)
