Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)
Zydus Lifesciences Limited
TOPICAL
PRESCRIPTION DRUG
Abbreviated New Drug Application
IVERMECTIN- IVERMECTIN CREAM ZYDUS LIFESCIENCES LIMITED ---------- IVERMECTIN CREAM SPL UNCLASSIFIED PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Ivermectin Cream, 1% 45 gm NDC 70771-1728-4 Rx only IVERMECTIN ivermectin cream PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1728 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) IVERMECTIN 10 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Zydus Lifesciences Limited SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) PRODUCT CHARACTERISTICS COLOR WHITE (white to pale yellow) SCORE SHAPE SIZE FLAVOR IMPRINT CODE CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1728-2 1 in 1 CARTON 06/10/2023 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70771- 1728-4 1 in 1 CARTON 06/10/2023 2 45 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70771- 1728-3 1 in 1 CARTON 06/10/2023 3 60 g in 1 TUBE; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA215210 06/10/2023 LABELER - Zydus Lifesciences Limited (918596198) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1728) , MANUFACTURE(70771-1728) Revised: 6/2023 সম্পূর্ণ নথি পড়ুন