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USFDA APPLICATION NUMBER - 19516 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| morphine sulfate(UNII: X3P646A2J0) (morphine - UNII:76I7G6D29C) | morphine sulfate | 15mg |
Inactive Ingredients
| Ingredient Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | Sun Pharmaceutical Industries, Inc. | St Marys Medical Park Pharmacy | Zydus Pharmaceuticals (USA) Inc. | Avera McKennan Hospital | Bryant Ranch Prepack | Cardinal Health | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | Watson Laboratories, Inc. | Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc. | Quality Care Products, LLC | American Health Packaging | Mylan Pharmaceuticals Inc. | Par Pharmaceutical | Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | |||||||||||||||||
| ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||||||||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | |||||||||||||||||
| BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | |||||||||||||||||
| CARNAUBA WAX(R12CBM0EIZ) | |||||||||||||||||
| CETOSTEARYL ALCOHOL(2DMT128M1S) | |||||||||||||||||
| D&C RED NO. 27(2LRS185U6K) | |||||||||||||||||
| D&C RED NO. 30(2S42T2808B) | |||||||||||||||||
| D&C RED NO. 7(ECW0LZ41X8) | |||||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | |||||||||||||||||
| FD&C RED NO. 40(WZB9127XOA) | |||||||||||||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | |||||||||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||||||||||||||||
| FERRIC OXIDE RED(1K09F3G675) | |||||||||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||||||
| HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(8136Y38GY5) | |||||||||||||||||
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(8136Y38GY5) | |||||||||||||||||
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16) | |||||||||||||||||
| HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)(12VCE9HR9E) | |||||||||||||||||
| HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(ZYD53NBL45) | |||||||||||||||||
| HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | |||||||||||||||||
| hydroxypropyl cellulose(RFW2ET671P) | |||||||||||||||||
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14) | |||||||||||||||||
| HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K) | |||||||||||||||||
| HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2) | |||||||||||||||||
| HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | |||||||||||||||||
| HYPROMELLOSE(3NXW29V3WO) | |||||||||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||||||
| lactose(J2B2A4N98G) | |||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||||
| POLYDEXTROSE(VH2XOU12IE) | |||||||||||||||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | |||||||||||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||||||||||||||
| POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | |||||||||||||||||
| polyethylene glycol(3WJQ0SDW1A) | |||||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||||||||||
| POLYSORBATE 80(6OZP39ZG8H) | |||||||||||||||||
| POLYVINYL ALCOHOL(532B59J990) | |||||||||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||||||
| POWDERED CELLULOSE(SMD1X3XO9M) | |||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||||
| STEARIC ACID(4ELV7Z65AP) | |||||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||||||||
| TRIACETIN(XHX3C3X673) |
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