
USFDA APPLICATION NUMBER - 210875 / DOSAGE - FILM;SUBLINGUAL - 10MG
| 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) |