Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
SUCCINYLCHOLINE CHLORIDE (UNII: I9L0DDD30I) (SUCCINYLCHOLINE - UNII:J2R869A8YF)
Liva Pharmaceuticals Limited
INTRAMUSCULAR
PRESCRIPTION DRUG
Abbreviated New Drug Application
SUCCINYLCHOLINE CHLORIDE- SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION LIVA PHARMACEUTICALS LIMITED ---------- 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 Pročitajte cijeli dokument