
USFDA APPLICATION NUMBER - 17354 / DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ETHINYL ESTRADIOL(UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) | ETHINYL ESTRADIOL | 0.02mg | 0.03mg |
| NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S) | NORETHINDRONE ACETATE | 1mg | 1.5mg |
Inactive Ingredients
| Ingredient Name | Actavis Pharma, Inc. | Mayne Pharma Inc. | RPK Pharmaceuticals, Inc. |
|---|---|---|---|
| ACACIA(5C5403N26O) | |||
| D&C YELLOW NO. 10(35SW5USQ3G) | |||
| FD&C BLUE NO. 1(H3R47K3TBD) | |||
| FD&C YELLOW NO. 6(H77VEI93A8) | |||
| FERROUS FUMARATE(R5L488RY0Q) | |||
| LACTOSE(J2B2A4N98G) | |||
| LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||
| MAGNESIUM STEARATE(70097M6I30) | |||
| MANNITOL(3OWL53L36A) | |||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | |||
| STARCH, CORN(O8232NY3SJ) | |||
| SUCROSE(C151H8M554) | |||
| SUGARCANE(81H2R5AOH3) | |||
| TALC(7SEV7J4R1U) |