INSTANYL- fentanyl nasal spray spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)
Available from:
Renaissance Lakewood LLC
Administration route:
NASAL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Export only
Authorization number:
49396-0512-1

INSTANYL- fentanyl nasal spray spray

Renaissance Lakewood LLC

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Instanyl Fentanyl Nasal Spray

Device Label

INSTANYL

fentanyl nasal spray spray

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:49 39 6 -0 512

Route of Administration

NASAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FENTANYL CITRATE (UNII: MUN5LYG46 H) (FENTANYL - UNII:UF59 9 78 5JZ)

FENTANYL

2 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 39 6 -0 512-1

50 in 1 CARTON

0 6 /29 /20 11

1

0 .125 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Expo rt o nly

0 6 /29 /20 11

Labeler -

Renaissance Lakewood LLC (077744035)

Registrant -

Renaissance Lakewood LLC (077744035)

Renaissance Lakewood LLC

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 -0 512) , analysis(49 39 6 -0 512)

Revised: 9/2019

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