DIAZOXIDE ORAL SOLUTION- diazoxide oral suspension suspension

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

DIAZOXIDE (UNII: O5CB12L4FN) (DIAZOXIDE - UNII:O5CB12L4FN)

Prieinama:

TriRx Huntsville Pharmaceutical Services LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DIAZOXIDE ORAL SOLUTION- DIAZOXIDE ORAL SUSPENSION SUSPENSION
TRIRX HUNTSVILLE PHARMACEUTICAL SERVICES LLC
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DIAZOXIDE ORAL SUSPENSION, USP
DIAZOXIDE ORAL SOLUTION
diazoxide oral suspension suspension
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:80432-057
ROUTE OF ADMINISTRATION
ORAL
TriRx Huntsville Pharmaceutical Services LLC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIAZOXIDE (UNII: O5CB12L4FN) (DIAZOXIDE - UNII:O5CB12L4FN)
DIAZ OXIDE
50 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
METHYLPARABEN (UNII: A2I8C7HI9T)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER
SACCHARIDE;
100-200 MPA.S AT 1%) (UNII: 99H65D77XY)
PROPYLENE OXIDE (UNII: Y4Y7NYD4BK)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)
HYDROCHLORIC ACID (UNII: QTT17582CB)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:80432-
057-06
1 in 1 CARTON
01/06/2023
1
30 mL in 1 BOTTLE, DROPPER; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA211050
01/06/2023
LABELER -
TriRx Huntsville Pharmaceutical Services LLC (117090286)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
TriRx Huntsville Pharmaceutical Services, LLC
117090286
manufacture(80432-057)
Revised: 1/2023