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USFDA APPLICATION NUMBER - 20198 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| NIFEDIPINE(UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L) | NIFEDIPINE | 90mg | 60mg | 30mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | REMEDYREPACK INC. | Almatica Pharma Inc. | Alvogen Inc. | Bayer HealthCare Pharmaceuticals Inc. |
|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||
| CROSPOVIDONE (120 .MU.M)(68401960MK) | |||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |||||
| CROSPOVIDONE(68401960MK) | |||||
| FERRIC OXIDE RED(1K09F3G675) | |||||
| HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F) | |||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |||||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||
| HYPROMELLOSES(3NXW29V3WO) | |||||
| LACTOSE(J2B2A4N98G) | |||||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||||
| MAGNESIUM STEARATE(70097M6I30) | |||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | |||||
| STARCH, CORN(O8232NY3SJ) | |||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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