USFDA APPLICATION NUMBER - 21127 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
AZELASTINE HYDROCHLORIDE(UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X) | AZELASTINE HYDROCHLORIDE | 0.5mg in 1 |
Inactive Ingredients
Ingredient Name | Meda Pharmaceuticals Inc. | Wallace Pharmaceuticals Inc. |
---|---|---|
BENZALKONIUM CHLORIDE(F5UM2KM3W7) | ||
EDETATE DISODIUM(7FLD91C86K) | ||
HYPROMELLOSES(3NXW29V3WO) | ||
SODIUM HYDROXIDE(55X04QC32I) | ||
SORBITOL(506T60A25R) | ||
WATER(059QF0KO0R) |
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