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USFDA APPLICATION NUMBER - 22321 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C) | MORPHINE SULFATE | 100mg | 80mg | 60mg | 50mg | 30mg | 20mg |
| NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM) | NALTREXONE HYDROCHLORIDE | 4mg | 3.2mg | 2.4mg | 2mg | 1.2mg | 0.8mg |
Inactive Ingredients
| Ingredient Name | Pfizer Laboratories Div Pfizer Inc |
|---|---|
| AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2) | |
| ASCORBIC ACID(PQ6CK8PD0R) | |
| D&C RED NO. 28(767IP0Y5NH) | |
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| DIBUTYL SEBACATE(4W5IH7FLNY) | |
| DIETHYL PHTHALATE(UF064M00AF) | |
| ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C RED NO. 3(PN2ZH5LOQY) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FD&C YELLOW NO. 6(H77VEI93A8) | |
| GELATIN, UNSPECIFIED(2G86QN327L) | |
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | |
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |
| SODIUM CHLORIDE(451W47IQ8X) | |
| SODIUM LAURYL SULFATE(368GB5141J) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |
