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Balcoltra Approval History

FDA Approved: Yes (First approved January 9, 2018)
Brand name: Balcoltra
Generic name: ethinyl estradiol/levonorgestrel and ferrous bisglycinate
Dosage form: Tablets
Company: Avion Pharmaceuticals, LLC
Treatment for: Birth Control

Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.

Development History and FDA Approval Process for Balcoltra

DateArticle
Jan 17, 2018Approval Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive

Further information

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