EPINEPHRINE HYPOSPRAY(R) bitartrate aerosol

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Fáanlegur frá:

Langford Research Institute

INN (Alþjóðlegt nafn):

EPINEPHRINE

Samsetning:

EPINEPHRINE 1 mg in 1 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Investigational New Drug Application

Vara einkenni

EPINEPHRINE HYPOSPRAY(R)- EPINEPHRINE BITARTRATE AEROSOL, SPRAY
LANGFORD RESEARCH INSTITUTE
----------
EPINEPHRINE HYPOSPRAY
EPINEPHRINE HYPOSPRAY
For Topical Application. To be applied in
accordance with enclosed instructions.
EPINEPHRINE HYPOSPRAY
For Clinical Trial Use Only
EudraCT No: 2017-000000-00
Subject number: S/R _____
For topical application. To be applied in accordance with enclosed
instructions
Investigator: Prof S. L. Chew
Use by: 07 / 2017
Batch no: TDSE-002
Store at room temperature
Barts Health Pharmacy Production
Caution – Limited by Law to Investigational Use
Mfr By LRI, Florida License 20337 NDC 070304-002-01
See CDER Direct Epi Label image
EPINEPHRINE HYPOSPRAY(R)
epinephrine bitartrate aerosol, spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:70 30 4-0 0 2
ROUTE OF ADMINISTRATION
TRANSDERMAL
Langford Research Institute
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
EPINEPHRINE (UNII: YKH8 34O4BH) (EPINEPHRINE - UNII:YKH8 34O4BH)
EPINEPHRINE
1 mg in 1 mg
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70 30 4-0 0 2-
0 1
1 mg in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n
Pro duc t
10 /10 /20 16
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
IND
IND132473
10 /10 /20 16
LABELER -
Langford Research Institute (933253341)
REGISTRANT -
Langford Research Institute (933253341)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Langfo rd Research Institute
9 33253341
ma nufa c ture (70 30 4-0 0 2)
Revised: 12/2016