
USFDA APPLICATION NUMBER - 21990 / DOSAGE - TABLET;ORAL - EQ 10MG BASE;160MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) | AMLODIPINE | 5mg |
| VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) | VALSARTAN | 160mg |
Inactive Ingredients
| Ingredient Name | Teva Pharmaceuticals USA, Inc. | AvKARE, Inc. | Novel Laboratories, Inc. | REMEDYREPACK INC. | Trigen Laboratories, LLC | Torrent Pharmaceuticals Limited | A-S Medication Solutions | Sandoz Inc | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | Mylan Pharmaceuticals Inc. | Aurobindo Pharma Limited | LUPIN LIMITED | Lupin Pharmaceuticals, Inc. | medsource pharmaceuticals |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J) | |||||||||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |||||||||||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||||||||||||
| CROSPOVIDONE(2S7830E561) | |||||||||||||||
| CROSPOVIDONE(68401960MK) | |||||||||||||||
| CROSPOVIDONE, UNSPECIFIED(2S7830E561) | |||||||||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||||
| 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 2910 (6 MPA.S)(0WZ8WG20P6) | |||||||||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||||
| HYPROMELLOSES(3NXW29V3WO) | |||||||||||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | |||||||||||||||
| MAGNESIUM STEARATE(70097M6I30) | |||||||||||||||
| MANNITOL(3OWL53L36A) | |||||||||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | |||||||||||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |||||||||||||||
| POLYETHYLENE GLYCOL 4000(4R4HFI6D95) | |||||||||||||||
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | |||||||||||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |||||||||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||||||||
| POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||||||
| POVIDONE K30(U725QWY32X) | |||||||||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||||||||||||||
| SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985) | |||||||||||||||
| STARCH, CORN(O8232NY3SJ) | |||||||||||||||
| TALC(7SEV7J4R1U) | |||||||||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |