USFDA APPLICATION NUMBER - 50808 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 105MG 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 | Teva Pharmaceuticals USA, Inc. | Mylan Pharmaceuticals Inc. | Oceanside Pharmaceuticals | Dr. Reddys Laboratories 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) | ||||||
Ethylcellulose (10 Mpa.S)(3DYK7UYZ62) | ||||||
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) | ||||||
Hydroxypropyl Cellulose (Type H)(RFW2ET671P) | ||||||
HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T) | ||||||
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | ||||||
HYPROMELLOSE 2910 (4000 MPA.S)(RN3152OP35) | ||||||
Hypromellose 2910 (5 Mpa.S)(R75537T0T4) | ||||||
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N) | ||||||
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||
INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | ||||||
Isopropyl Alcohol(ND2M416302) | ||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||
MAGNESIUM STEARATE(70097M6I30) | ||||||
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||||
Polyethylene Glycol 400(B697894SGQ) | ||||||
POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | ||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
PROPYLENE GLYCOL(6DC9Q167V3) | ||||||
SHELLAC(46N107B71O) | ||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||
Sodium Stearyl Fumarate(7CV7WJK4UI) | ||||||
Talc(7SEV7J4R1U) | ||||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||||
TRIACETIN(XHX3C3X673) | ||||||
Triethyl Citrate(8Z96QXD6UM) | ||||||
Water(059QF0KO0R) |
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