Azelastine Hydrochloride Spray, Metered [Cadila Healthcare Limited] -

AZELASTINE HYDROCHLORIDE SPRAY, METERED [CADILA HEALTHCARE LIMITED]
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NDC	70771-1313-2
Set ID	b8d32cf2-8068-4659-b088-ee51cbf18604
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Cadila Healthcare Limited
Generic Name
Product Class
Product Number
Application Number	ANDA091409

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INGREDIENTS AND APPEARANCE

AZELASTINE HYDROCHLORIDE
azelastine hydrochloride spray, metered

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)	AZELASTINE HYDROCHLORIDE	137 ug

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1313-2	1 in 1 CARTON	02/01/2018
1		200 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091409	02/01/2018

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Cadila Healthcare Limited		918596198	ANALYSIS(70771-1313) , MANUFACTURE(70771-1313)

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Medic