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USFDA APPLICATION NUMBER - 20353 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| naproxen sodium(UNII: 9TN87S3A3C) (naproxen - UNII:57Y76R9ATQ) | naproxen sodium | 750mg | 500mg | 375mg |
Inactive Ingredients
| Ingredient Name | Bryant Ranch Prepack | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | Victory Pharma, Inc. | Actavis Pharma, Inc. |
|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |||||
| cellulose, microcrystalline(OP1R32D61U) | |||||
| crospovidone (15 mpa.s at 5%)(68401960MK) | |||||
| crospovidone(2S7830E561) | |||||
| CROSPOVIDONE(68401960MK) | |||||
| ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(P2OM2Q86BI) | |||||
| FERROSOFERRIC OXIDE(XM0M87F357) | |||||
| FUMARIC ACID(88XHZ13131) | |||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |||||
| hypromellose, unspecified(3NXW29V3WO) | |||||
| HYPROMELLOSES (3NXW29V3WO) | |||||
| HYPROMELLOSES(3NXW29V3WO) | |||||
| magnesium stearate(70097M6I30) | |||||
| microcrystalline cellulose(OP1R32D61U) | |||||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | |||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||
| POLYSORBATE 80(6OZP39ZG8H) | |||||
| povidone(FZ989GH94E) | |||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||
| PROPYLENE GLYCOL(6DC9Q167V3) | |||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||
| talc(7SEV7J4R1U) | |||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
