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USFDA APPLICATION NUMBER - 21830 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| MESALAMINE(UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) | MESALAMINE | 800mg |
Inactive Ingredients
| Ingredient Name | American Health Packaging | Allergan, Inc. |
|---|---|---|
| DIBUTYL PHTHALATE(2286E5R2KE) | ||
| DIBUTYL SEBACATE(4W5IH7FLNY) | ||
| FERRIC OXIDE RED(1K09F3G675) | ||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J) | ||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13) | ||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577) | ||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||
| POVIDONE(FZ989GH94E) | ||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||
| POVIDONES(FZ989GH94E) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||
| SODIUM STARCH GLYCOLATE TYPE A(H8AV0SQX4D) | ||
| TALC(7SEV7J4R1U) |
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