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USFDA APPLICATION NUMBER - 20254 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| DICLOFENAC SODIUM(UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) | DICLOFENAC SODIUM | 100mg |
Inactive Ingredients
| Ingredient Name | Bryant Ranch Prepack | Lake Erie Medical DBA Quality Care Products LLC | PD-Rx Pharmaceuticals, Inc. | Preferred Pharmaceuticals, Inc. | Proficient Rx LP | Sandoz Inc |
|---|---|---|---|---|---|---|
| CETYL ALCOHOL(936JST6JCN) | ||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||
| HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | ||||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||||||
| HYDROXYPROPYL CELLULOSE(RFW2ET671P) | ||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||
| POVIDONE(FZ989GH94E) | ||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||
| POVIDONES(FZ989GH94E) | ||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||
| SUCROSE(C151H8M554) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
