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USFDA APPLICATION NUMBER - 205637 / DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) | BUPRENORPHINE | 6.3mg | 4.2mg | 2.1mg |
| naloxone hydrochloride dihydrate(UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N) | NALOXONE | 1mg | 0.7mg | 0.3mg |
Inactive Ingredients
| Ingredient Name | BioDelivery Sciences International, Inc. |
|---|---|
| .ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0) | |
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |
| CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(YGX74DKE74) | |
| DIBASIC POTASSIUM PHOSPHATE(CI71S98N1Z) | |
| Ferric Oxide Yellow(EX438O2MRT) | |
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(8136Y38GY5) | |
| HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | |
| Methylparaben(A2I8C7HI9T) | |
| Polycarbophil(W25LM17A4W) | |
| Propylene Glycol(6DC9Q167V3) | |
| Propylparaben(Z8IX2SC1OH) | |
| Saccharin Sodium(SB8ZUX40TY) | |
| Sodium Benzoate(OJ245FE5EU) | |
| Sodium Hydroxide(55X04QC32I) | |
| SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU) |
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