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USFDA APPLICATION NUMBER - 22100 / DOSAGE - TABLET;ORAL - EQ 5MG BASE;40MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) | AMLODIPINE | 10mg | 5mg | 10mg | 5mg |
| OLMESARTAN MEDOXOMIL(UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) | OLMESARTAN MEDOXOMIL | 40mg | 40mg | 20mg | 20mg |
Inactive Ingredients
| Ingredient Name | Aurobindo Pharma Limited | Bryant Ranch Prepack | Jubilant Cadista Pharmaceuticals Inc. | Alembic Pharmaceuticals Inc. | Apotex Corp. | Macleods Pharmaceuticals Limited | medsource pharmaceuticals | Micro Labs Limited | Physicians Total Care, Inc. | Ajanta Pharma USA Inc. | Ascend Laboratories, LLC | AvKARE, Inc. | Glenmark Pharmaceuticals Inc., USA | ScieGen Pharmaceuticals, Inc | Torrent Pharmaceuticals Limited | Teva Pharmaceuticals USA, Inc. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ANHYDROUS LACTOSE(3SY5LH9PMK) | ||||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||||||||||||||
| CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9) | ||||||||||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||||||||
| 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) | ||||||||||||||||
| HYDROGENATED CASTOR OIL(ZF94AP8MEY) | ||||||||||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||||||||||
| MANNITOL(3OWL53L36A) | ||||||||||||||||
| MEGLUMINE(6HG8UB2MUY) | ||||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||||||||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||||||||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | ||||||||||||||||
| POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | ||||||||||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||||||||
| POLYVINYL ALCOHOL(532B59J990) | ||||||||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||||||||||||||
| POVIDONE K30(U725QWY32X) | ||||||||||||||||
| POVIDONE(FZ989GH94E) | ||||||||||||||||
| Powdered Cellulose(SMD1X3XO9M) | ||||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||||||||
| SODIUM HYDROXIDE(55X04QC32I) | ||||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||||||||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||||||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||||||||||
| STARCH, POTATO(8I089SAH3T) | ||||||||||||||||
| STEARIC ACID(4ELV7Z65AP) | ||||||||||||||||
| SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE(B357P1G1IF) | ||||||||||||||||
| TALC(7SEV7J4R1U) | ||||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
