USFDA APPLICATION NUMBER - 210875 / DOSAGE - FILM;SUBLINGUAL - 25MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
apomorphine hydrochloride(UNII: F39049Y068) (apomorphine - UNII:N21FAR7B4S) | apomorphine hydrochloride | 30mg | 25mg | 25mg | 20mg | 30mg | 15mg | 15mg | 20mg | 10mg | 10mg |
Inactive Ingredients
Ingredient Name | Sunovion Pharmaceuticals Inc. |
---|---|
acetone(1364PS73AF) | |
alcohol(3K9958V90M) | |
edetate disodium(7FLD91C86K) | |
FD&C Blue no. 1(H3R47K3TBD) | |
Glycerin(PDC6A3C0OX) | |
glyceryl monostearate(230OU9XXE4) | |
hydroxyethyl cellulose (140 MPA.S AT 5%)(8136Y38GY5) | |
Hydroxyethyl cellulose (280 MPA.S AT 2%)(12VCE9HR9E) | |
hydroxypropyl cellulose (45000 wamw)(8VAB711C5E) | |
maltodextrin(7CVR7L4A2D) | |
menthol(L7T10EIP3A) | |
Pyridoxine hydrochloride(68Y4CF58BV) | |
sodium hydroxide(55X04QC32I) | |
sodium metabisulfite(4VON5FNS3C) | |
Sucralose(96K6UQ3ZD4) | |
water(059QF0KO0R) |
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