
USFDA APPLICATION NUMBER - 20907 / DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) | ESTRADIOL | 1mg | 0.5mg |
| NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S) | NORETHINDRONE ACETATE | 0.5mg | 0.1mg |
Inactive Ingredients
| Ingredient Name | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals NY LLC | Gemini Laboratories, LLC | Novo Nordisk |
|---|---|---|---|---|
| COPOVIDONE K25-31(D9C330MD8B) | ||||
| COPOVIDONE(D9C330MD8B) | ||||
| HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F) | ||||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||||
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | ||||
| HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K) | ||||
| HYPROMELLOSES(3NXW29V3WO) | ||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| STARCH, CORN(O8232NY3SJ) | ||||
| TALC(7SEV7J4R1U) | ||||
| TRIACETIN(XHX3C3X673) |