USFDA APPLICATION NUMBER - 207932 / DOSAGE - FILM;BUCCAL - EQ 0.75MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) | BUPRENORPHINE | 75ug | 900ug | 750ug | 600ug | 450ug | 300ug | 150ug |
Inactive Ingredients
Ingredient Name | BioDelivery Sciences International Inc | Endo Pharmaceuticals, Inc. |
---|---|---|
.ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0) | ||
ALPHA-TOCOPHEROL ACETATE(9E8X80D2L0) | ||
ANHYDROUS CITRIC ACID(XF417D3PSL) | ||
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(YGX74DKE74) | ||
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311) | ||
Ferric Oxide Yellow(EX438O2MRT) | ||
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(8136Y38GY5) | ||
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(B24JYI97VR) | ||
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | ||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||
Methylparaben(A2I8C7HI9T) | ||
Peppermint Oil(AV092KU4JH) | ||
POLYCARBOPHIL(W25LM17A4W) | ||
PROPYLENE GLYCOL(6DC9Q167V3) | ||
PROPYLPARABEN(Z8IX2SC1OH) | ||
Saccharin Sodium(SB8ZUX40TY) | ||
Sodium Benzoate(OJ245FE5EU) | ||
Sodium Hydroxide(55X04QC32I) | ||
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU) | ||
Titanium Dioxide(15FIX9V2JP) | ||
WATER(059QF0KO0R) |
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