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USFDA APPLICATION NUMBER - 22410 / DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ) | BUPRENORPHINE HYDROCHLORIDE | 2mg |
| NALOXONE HYDROCHLORIDE(UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) | NALOXONE HYDROCHLORIDE | 0.5mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions LLC | Almatica Pharma Inc. | Alvogen Inc. | Apotex Corp. | Bryant Ranch Prepack | Dr.Reddys Laboratories Inc | Indivior Inc. | Mylan Pharmaceuticals Inc. | Quality Care Products, LLC |
|---|---|---|---|---|---|---|---|---|---|
| ACESULFAME POTASSIUM(23OV73Q5G9) | |||||||||
| ALCOHOL(3K9958V90M) | |||||||||
| AMMONIA(5138Q19F1X) | |||||||||
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | |||||||||
| BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | |||||||||
| CITRIC ACID MONOHYDRATE(2968PHW8QP) | |||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||
| HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | |||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | |||||||||
| maltitol(D65DG142WK) | |||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||
| POLYETHYLENE OXIDE 100000(V46Y6OJ5QB) | |||||||||
| POLYETHYLENE OXIDE 1000000(HZ58M6D839) | |||||||||
| POLYETHYLENE OXIDE 200000(11628IH70O) | |||||||||
| POLYETHYLENE OXIDE 2000000(5K3991GVWI) | |||||||||
| POLYETHYLENE OXIDE 900000(16P9295IIL) | |||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||
| POVIDONE K29/32(390RMW2PEQ) | |||||||||
| POVIDONE K30(U725QWY32X) | |||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||
| SHELLAC(46N107B71O) | |||||||||
| sodium citrate(1Q73Q2JULR) | |||||||||
| SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR) | |||||||||
| SODIUM METABISULFITE(4VON5FNS3C) | |||||||||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F) | |||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||
| TRISODIUM CITRATE DIHYDRATE(B22547B95K) |
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