AZELASTINE HYDROCHLORIDE spray, metered

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)

Disponível em:

Zydus Lifesciences Limited

Via de administração:

NASAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. None. Risk Summary Limited data from postmarketing experience over decades of use with Azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096

Resumo do produto:

Azelastine Hydrochloride Nasal Spray (137 mcg per spray) is supplied as a 30-mL package (NDC 70771-1313-2) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine Hydrochloride Nasal Spray should not be used after the expiration date "EXP" printed on the medicine label and carton. Storage   Store upright at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle upright, tightly closed, and away from children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE SPRAY, METERED
ZYDUS LIFESCIENCES LIMITED
----------
AZELASTINE HYDROCHLORIDE NASAL SOLUTION (NASAL SPRAY), 137 MCG
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1313-2
Azelastine Hydrochloride Nasal Spray, 137 mcg per spray
30 mL
Rx only
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride spray, metered
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1313
ROUTE OF ADMINISTRATION
NASAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE -
UNII:Z QI909440X)
AZ ELASTINE
HYDROCHLORIDE
137 ug
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
Zydus Lifesciences Limited
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)
HYPROMELLOSES (UNII: 3NXW29V3WO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:70771-
1313-2
1 in 1 CARTON
02/01/2018
1
200 in 1 BOTTLE; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA091409
02/01/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1313) , MANUFACTURE(70771-1313)
Revised: 10/2022