IVERMECTIN cream

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)

Dostupné s:

Zydus Lifesciences Limited

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

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