SPRAVATO- esketamine spray

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ESKETAMINE (UNII: 50LFG02TXD) (ESKETAMINE - UNII:50LFG02TXD)

Disponible depuis:

Renaissance Lakewood LLC

Mode d'administration:

NASAL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Export only

Résumé des caractéristiques du produit

SPRAVATO- ESKETAMINE SPRAY
RENAISSANCE LAKEWOOD LLC
----------
SPRAVATO (ESKETAMINE) EMA
RENAISSANCE LABEL
SPRAVATO
esketamine spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:49 39 6 -0 28 0
ROUTE OF ADMINISTRATION
NASAL
DEA SCHE DULE
CIII
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ESKETAMINE (UNII: 50 LFG0 2TXD) (ESKETAMINE - UNII:50 LFG0 2TXD)
ESKETAMINE
28 mg
Renaissance Lakewood LLC
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:49 39 6 -
0 28 0 -2
2 in 1 CARTON
12/18 /20 19
1
1 in 1 BLISTER PACK
1
1 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe,
patch, etc.)
2
NDC:49 39 6 -
0 28 0 -3
3 in 1 CARTON
12/18 /20 19
2
1 in 1 BLISTER PACK
2
1 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe,
patch, etc.)
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
Expo rt o nly
12/18 /20 19
LABELER -
Renaissance Lakewood LLC (077744035)
REGISTRANT -
Renaissance Lakewood LLC (077744035)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Renaissance Lakewo o d LLC
0 777440 35
manufacture(49 39 6 -0 28 0 ) , analysis(49 39 6 -0 28 0 )
Revised: 12/2019