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USFDA APPLICATION NUMBER - 50808 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 55MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| minocycline hydrochloride(UNII: 0020414E5U) (minocycline - UNII:FYY3R43WGO) | minocycline | 105mg | 80mg | 55mg |
Inactive Ingredients
| Ingredient Name | Bryant Ranch Prepack | Mylan Pharmaceuticals Inc. | Oceanside Pharmaceuticals | Lupin Pharmaceuticals, Inc. | NorthStar Rx LLC |
|---|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | |||||
| AMMONIA(5138Q19F1X) | |||||
| CARNAUBA WAX(R12CBM0EIZ) | |||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||
| D&C Red No. 27(2LRS185U6K) | |||||
| 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. 6(H77VEI93A8) | |||||
| FERRIC OXIDE RED(1K09F3G675) | |||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | |||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||
| HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T) | |||||
| HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | |||||
| HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | |||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | |||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||
| HYPROMELLOSES(3NXW29V3WO) | |||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||
| MAGNESIUM STEARATE(70097M6I30) | |||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | |||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||
| POLYSORBATE 80(6OZP39ZG8H) | |||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||
| SHELLAC(46N107B71O) | |||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||
| TALC(7SEV7J4R1U) | |||||
| TITANIUM DIOXIDE(15FIX9V2JP) | |||||
| TRIACETIN(XHX3C3X673) |
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