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USFDA APPLICATION NUMBER - 22511 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ESOMEPRAZOLE MAGNESIUM(UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) | ESOMEPRAZOLE | 20mg | 20mg |
| NAPROXEN(UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ) | NAPROXEN | 375mg | 500mg |
Inactive Ingredients
| Ingredient Name | AstraZeneca LP |
|---|---|
| CARNAUBA WAX(R12CBM0EIZ) | |
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |
| FERRIC OXIDE YELLOW(EX438O2MRT) | |
| FERROSOFERRIC OXIDE(XM0M87F357) | |
| GLYCERYL MONOSTEARATE(230OU9XXE4) | |
| HYPROMELLOSES(3NXW29V3WO) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHACRYLIC ACID(1CS02G8656) | |
| METHYLPARABEN(A2I8C7HI9T) | |
| POLYDEXTROSE(VH2XOU12IE) | |
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |
| POLYSORBATE 80(6OZP39ZG8H) | |
| POVIDONE(FZ989GH94E) | |
| PROPYLPARABEN(Z8IX2SC1OH) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| TITANIUM DIOXIDE(15FIX9V2JP) | |
| TRIETHYL CITRATE(8Z96QXD6UM) |
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