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USFDA APPLICATION NUMBER - 205831 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49) | METHYLPHENIDATE HYDROCHLORIDE | 10mg | 15mg | 20mg | 30mg | 40mg | 50mg | 60mg |
Inactive Ingredients
| Ingredient Name | Actavis Pharma, Inc. | Actavis South Atlantic LLC | American Health Packaging | Avera McKennan Hospital | Mayne Pharma | Teva Pharmaceuticals USA, Inc. | Granules Pharmaceuticals Inc. | Rhodes Pharmaceuticals L.P. | CorePharma, LLC | Kremers Urban Pharmaceuticals Inc. | Mckesson Rxpak Inc | Unither Manufacturing, LLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACETONE(1364PS73AF) | ||||||||||||
| ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ) | ||||||||||||
| AMMONIA(5138Q19F1X) | ||||||||||||
| AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2) | ||||||||||||
| CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(BEI30UXK2N) | ||||||||||||
| CELLULOSE ACETATE(3J2P07GVB6) | ||||||||||||
| CETYL ALCOHOL(936JST6JCN) | ||||||||||||
| D&C RED NO. 28(767IP0Y5NH) | ||||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | ||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||||
| dibutyl sebacate(4W5IH7FLNY) | ||||||||||||
| ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | ||||||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||
| FD&C Blue No. 2(L06K8R7DQK) | ||||||||||||
| FD&C GREEN NO. 3(3P3ONR6O1S) | ||||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | ||||||||||||
| 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) | ||||||||||||
| GELATIN(2G86QN327L) | ||||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||||||
| HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W) | ||||||||||||
| HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(36BGF0E889) | ||||||||||||
| hypromellose, unspecified(3NXW29V3WO) | ||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||||
| METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J) | ||||||||||||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||||
| SHELLAC(46N107B71O) | ||||||||||||
| SHELLAC(MB5IUD6JUA) | ||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||||
| SUCROSE(C151H8M554) | ||||||||||||
| TALC(7SEV7J4R1U) | ||||||||||||
| titanium dioxide(15FIX9V2JP) | ||||||||||||
| TRIETHYL CITRATE(8Z96QXD6UM) | ||||||||||||
| WATER(059QF0KO0R) |
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