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USFDA APPLICATION NUMBER - 17078 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI) | DEXTROAMPHETAMINE SULFATE | 15mg | 5mg | 10mg |
Inactive Ingredients
| Ingredient Name | American Health Packaging | Vensun Pharmaceuticals, LLC. | Mylan Pharmaceuticals Inc. | Amedra Pharmaceuticals LLC | Amneal Pharmaceuticals of New York LLC | Lineage Therapeutics Inc | Par Pharmaceutical | Avera McKennan Hospital | Teva Pharmaceuticals, USA, Inc. | Zydus Pharmaceuticals (USA) Inc. |
|---|---|---|---|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | ||||||||||
| ALUMINUM OXIDE(LMI26O6933) | ||||||||||
| AMMONIA(5138Q19F1X) | ||||||||||
| BUTYL ALCOHOL(8PJ61P6TS3) | ||||||||||
| CETYL ALCOHOL(936JST6JCN) | ||||||||||
| D&C RED NO. 28(767IP0Y5NH) | ||||||||||
| D&C RED NO. 33(9DBA0SBB0L) | ||||||||||
| D&C RED NO. 7(ECW0LZ41X8) | ||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||
| DIBUTYL SEBACATE(4W5IH7FLNY) | ||||||||||
| ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | ||||||||||
| ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV) | ||||||||||
| ETHYLCELLULOSE (20 MPA.S)(BJG0S321QY) | ||||||||||
| ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | ||||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||
| 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) | ||||||||||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | ||||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||||||
| HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | ||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | ||||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||
| MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U) | ||||||||||
| METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8) | ||||||||||
| OLEIC ACID(2UMI9U37CP) | ||||||||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||
| POVIDONE K30(U725QWY32X) | ||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||||
| POVIDONES(FZ989GH94E) | ||||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||
| SHELLAC(46N107B71O) | ||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||
| SUCROSE(C151H8M554) | ||||||||||
| TALC(7SEV7J4R1U) | ||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||||
| WATER(059QF0KO0R) |
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