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USFDA APPLICATION NUMBER - 21303 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E) | AMPHETAMINE ASPARTATE MONOHYDRATE | 1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg |
| AMPHETAMINE SULFATE(UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E) | AMPHETAMINE SULFATE | 1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg |
| DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI) | DEXTROAMPHETAMINE SACCHARATE | 1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg |
| DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI) | DEXTROAMPHETAMINE SULFATE | 1.25mg | 2.5mg | 3.75mg | 5mg | 6.25mg | 7.5mg |
Inactive Ingredients
| Ingredient Name | Par Pharmaceutical, Inc. | American Health Packaging | Amneal Pharmaceuticals of New York LLC | Ascent Pharmaceuticals, Inc | Bryant Ranch Prepack | Actavis Pharma, Inc. | Zydus Pharmaceuticals (USA) Inc. | Amerigen Pharmaceuticals Inc. | Barr Laboratories Inc. | Sun Pharmaceutical Industries, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | ||||||||||
| AMMONIA(5138Q19F1X) | ||||||||||
| AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY) | ||||||||||
| AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2) | ||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||||||||
| CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES(U72Q2I8C85) | ||||||||||
| D&C RED NO. 28(767IP0Y5NH) | ||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | ||||||||||
| D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6) | ||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||
| DEHYDRATED ALCOHOL(3K9958V90M) | ||||||||||
| FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM) | ||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||
| FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584) | ||||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | ||||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||||||
| GELATIN(2G86QN327L) | ||||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||||||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | ||||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||||||
| HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | ||||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||||||||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | ||||||||||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)(XRK36F13ZZ) | ||||||||||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13) | ||||||||||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577) | ||||||||||
| METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J) | ||||||||||
| METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | ||||||||||
| POLYDEXTROSE(VH2XOU12IE) | ||||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | ||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||
| Shellac(46N107B71O) | ||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||
| SUCROSE(C151H8M554) | ||||||||||
| TALC(7SEV7J4R1U) | ||||||||||
| Tert-butyl alcohol(MD83SFE959) | ||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||||
| TRIACETIN(XHX3C3X673) | ||||||||||
| TRIETHYL CITRATE(8Z96QXD6UM) | ||||||||||
| WATER(059QF0KO0R) |
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