Estradiol and Norethindrone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Estradiol; Norethindrone Acetate.
Product ID | 50742-658_bb15ca3a-56be-430a-a34b-3c04b5c08aba |
NDC | 50742-658 |
Product Type | Human Prescription Drug |
Proprietary Name | Estradiol and Norethindrone Acetate |
Generic Name | Estradiol And Norethindrone Acetate |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2019-04-03 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA210612 |
Labeler Name | Ingenus Pharmaceuticals, LLC |
Substance Name | ESTRADIOL; NORETHINDRONE ACETATE |
Active Ingredient Strength | 1 mg/1; mg/1 |
Pharm Classes | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2019-04-03 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA210612 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-03 |
Marketing Category | ANDA |
Application Number | ANDA210612 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-04-03 |
Marketing Category | ANDA |
Application Number | ANDA210612 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-04-03 |
Marketing Category | ANDA |
Application Number | ANDA210612 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-04-03 |
Ingredient | Strength |
---|---|
ESTRADIOL | .5 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
0378-7294 | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol and norethindrone acetate |
0378-7295 | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol and norethindrone acetate |
50742-657 | Estradiol and Norethindrone Acetate | Estradiol and Norethindrone Acetate |
50742-658 | Estradiol and Norethindrone Acetate | Estradiol and Norethindrone Acetate |
60846-201 | Activella | estradiol and norethindrone acetate |
60846-202 | Activella | estradiol and norethindrone acetate |
68180-829 | AMABELZ | estradiol and norethindrone acetate |
68180-830 | AMABELZ | estradiol and norethindrone acetate |
51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate |
51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate |
0093-5455 | Mimvey | Estradiol and Norethindrone Acetate |
0093-5454 | Mimvey Lo | Estradiol and Norethindrone Acetate |