SUCCINYLCHOLINE CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)

Available from:

Liva Pharmaceuticals Limited

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION
LIVA PHARMACEUTICALS LIMITED
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SUCCINYLCHOLINE CHLORIDE INJECTION, USP
A SHORT-ACTING DEPOLARIZING SKELETAL MUSCLE RELAXANT.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vial Label
NDC 72785-0010-1
Succinylcholine Chloride Injection, USP
200 mg/10 mL (20 mg/mL)
For Intravenous or Intramuscular use.
10 mL Multiple-dose Vial
Rx only
Carton Label
NDC 72785-0010-7
Succinylcholine Chloride Injection, USP
200 mg/10 mL (20 mg/mL)
For Intravenous or Intramuscular use.
Store in refrigerator 2º to 8ºC (36º to 46ºF).
25 x 10 mL Multiple-dose Vial
Rx only
SUCCINYLCHOLINE CHLORIDE
succinylcholine chloride injection, solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:7278 5-0 0 10
ROUTE OF ADMINISTRATION
INTRAMUSCULAR, INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SUCCINYLCHO LINE CHLO RIDE (UNII: I9 L0 DDD30 I) (SUCCINYLCHOLINE -
UNII:J2R8 6 9 A8 YF)
SUCCINYLCHOLINE
CHLORIDE
20 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
1.8 mg in 1 mL
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
0 .2 mg in 1 mL
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
Liva Pharmaceuticals Limited
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:7278 5-0 0 10 -
7
25 in 1 TRAY
0 5/10 /20 18
1
NDC:7278 5-0 0 10 -
1
10 mL in 1 VIAL, MULTI-DOSE; Type 0 : No t a Co mbinatio n
Pro duc t
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
ANDA
ANDA20 9 46 7
0 5/10 /20 18
LABELER -
Liva Pharmaceuticals Limited (873671928)
REGISTRANT -
Cadila Healthcare Limited (918596198)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Liva Pharmaceuticals Limited
8 736 719 28
MANUFACTURE(7278 5-0 0 10 ) , ANALYSIS(7278 5-0 0 10 )
Revised: 5/2020