"68083-287-01" National Drug Code (NDC)

Azelastine Hydrochloride 1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) > 6 mL in 1 BOTTLE, PLASTIC
(Gland Pharma Limited)

NDC Code68083-287-01
Package Description1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) > 6 mL in 1 BOTTLE, PLASTIC
Product NDC68083-287
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAzelastine Hydrochloride
Non-Proprietary NameAzelastine Hydrochloride
Dosage FormSOLUTION/ DROPS
UsageINTRAOCULAR
Start Marketing Date20200225
Marketing Category NameANDA
Application NumberANDA210092
ManufacturerGland Pharma Limited
Substance NameAZELASTINE HYDROCHLORIDE
Strength.5
Strength Unitmg/mL
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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