FDA
Norethindrone Acetate; Ethinyl Estradiol; Ethinyl Estradiol; Ferrous Fumarate
Composition
- Active ingredients
- NORETHINDRONE ACETATE 75MG; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA208097.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Norethindrone Acetate; Ethinyl Estradiol; Ethinyl Estradiol; Ferrous Fumarate
- Active substance
- norethindrone acetate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Glenmark Pharms LTD
- Status
- Tentative approval
- FDA approval
- 22 Apr 2016
- Application
- ANDA208097-001