Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
The Ritedose Corporation
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
Abbreviated New Drug Application
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 Prečítajte si celý dokument