IPRATROPIUM BROMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Available from:

The Ritedose Corporation

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
THE RITEDOSE CORPORATION
----------
IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%
NDC 600687- 394-83
IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%
0.5 MG/2 ML
30 X 2.5 ML STERILE UNIT-DOSE VIALS,
EACH IN A FOIL POUCH
RX ONLY
FOR ORAL INHALATION ONLY
PRINCIPAL DISPLAY PANEL - IPRATROPIUM BROMIDE INHALATION SOLUTION 30
CT SINGLES CARTON
NDC 600687- 394-83
IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%
0.5 MG/2 ML
30 X 2.5 ML STERILE UNIT-DOSE VIALS,
EACH IN A FOIL POUCH
RX ONLY
FOR ORAL INHALATION ONLY
IPRATROPIUM BROMIDE
ipratropium bromide solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 530 2-0 46
ROUTE OF ADMINISTRATION
RESPIRATORY (INHALATION)
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
IPRATRO PIUM BRO MIDE (UNII: J6 9 7UZ2A9 J) (IPRATROPIUM -
UNII:GR8 8 G0 I6 UL)
IPRATROPIUM BROMIDE
ANHYDROUS
0 .5 mg
in 2.5 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
The Ritedose Corporation
HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 530 2-0 46 -0 1 30 in 1 CARTON
12/26 /20 18
1
1 in 1 POUCH
1
2.5 mL in 1 AMPULE; 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
ANDA
ANDA0 756 9 3
12/26 /20 18
LABELER -
T he Ritedose Corporation (837769546)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
The Ritedo se
Co rpo ra tio n
8 3776 9 546
analysis(6 530 2-0 46 ) , manufacture(6 530 2-0 46 ) , pack(6 530 2-0
46 ) , label(6 530 2-
0 46 )
Revised: 12/2019